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NuVasive Merger
−Removed: On September 1, 2023, pursuant to that certain merger agreement (the “Merger Agreement”) with NuVasive, Inc.
−Removed: (“NuVasive”) and Zebra Merger Sub Inc.
−Removed: (“Merger Sub”), Merger Sub, a wholly owned subsidiary of the Company, merged with and into NuVasive, with NuVasive surviving as a wholly owned subsidiary of the Company (the “NuVasive Merger”).
−Removed: Under the Merger Agreement, each share of common stock, par value $0.001 per share, of NuVasive issued and outstanding immediately prior to the effective time of the NuVasive Merger (other than certain excluded shares as described in the Merger Agreement) was cancelled and converted into the right to receive 0.75 fully paid and non-assessable shares of Class A common stock of Globus, $0.001 par value per share, and the right to receive cash in lieu of fractional shares.
+Added: As previously disclosed, on September 1, 2023, pursuant to that certain merger agreement (the “NuVasive Merger Agreement”) with NuVasive, Inc.
+Added: (“NuVasive”) and Zebra Merger Sub Inc., a wholly owned subsidiary of the Company (“Zebra Merger Sub”), Zebra Merger Sub, merged with and into NuVasive, with NuVasive surviving as a wholly owned subsidiary of the Company (the “NuVasive Merger”).
+Added: Under the NuVasive Merger Agreement, each share of common stock, par value $0.001 per share, of NuVasive issued and outstanding immediately prior to the effective time of the NuVasive Merger (other than certain excluded shares as described in the NuVasive Merger Agreement) was cancelled and converted into the right to receive 0.75 fully paid and non-assessable shares of Class A common stock of Globus, $0.001 par value per share, and the right to receive cash in lieu of fractional shares.
+Added: As previously disclosed, on April 3, 2025, pursuant to the terms of that certain merger agreement (the “Nevro Merger Agreement”) with Nevro Corp.
+Added: (“Nevro”) and Palmer Merger Sub, Inc., a wholly owned subsidiary of the Company (“Palmer Merger Sub”), Palmer Merger Sub merged with and into Nevro (the “Nevro Merger” and, together with the NuVasive Merger, the NuVasive and Nevro Mergers”), with Nevro surviving as a wholly owned subsidiary of the Company.
+Added: Upon the consummation of the Nevro Merger, each issued and outstanding share of common stock of Nevro, $0.001 par value per share, was cancelled and converted into the right to receive cash in an amount equal to $5.85 per share of common stock of Nevro, without interest and subject to any applicable withholding taxes.
Overall Business
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We believe our team-oriented and highly-integrated development approach, active surgeon input, and demonstrated performance position us to maintain a rapid rate of new product launches.
−Removed: We launched 18 new products in 2024, including the ExcelsiusHub™ and the ExcelsiusFlex™ surgical navigation system.
+Added: We launched 9 new
+Added: products in 2025, including Excelsius XR ® to further expand our Excelsius ® ecosystem and Reline TM 3D Towers increasing our spinal products portfolio.
We have a range of new products in various stages of development and expect to continue to regularly launch new products.
• Increase the size, scope and productivity of our exclusive U.S.
−Removed: sales force .
We believe there is significant opportunity for us to further penetrate existing markets, and to enter new markets, by increasing the size and geographic scope of our exclusive U.S.
sales force for Musculoskeletal Solutions.
−Removed: Through the NuVasive Merger, we have significantly grown our U.S.
+Added: Through the NuVasive and Nevro Mergers, we have significantly grown our U.S.
We expect to continue to increase the number of our direct and distributor sales representatives in the U.S., to expand into new geographic territories and to deepen our penetration in existing territories.
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• Continue to expand into international markets.
−Removed: As of December 31, 2024, we had an existing direct or distributor sales presence in 65 countries outside the U.S.
+Added: As of December 31, 2025, we had an existing direct or distributor sales presence in 64 countries outside of the U.S.
We expect to continue to increase our international presence through the commercialization of additional Musculoskeletal Solutions products in current markets and through the expansion of our international sales force in current and new markets.
• Pursue strategic acquisitions.
−Removed: In 2017, we acquired KB Medical SA, developer of a computer-assisted robotic guidance system, and in 2018 we acquired Nemaris Inc., a company that markets and develops Surgimap ® , a leading surgical planning software platform, to further bolster our efforts to advance surgical procedures through Enabling Technologies.
−Removed: In 2019, we acquired substantially all of the assets of StelKast, Inc., a company that designs, manufactures and distributes orthopedic implants for knee and hip replacement surgeries.
+Added: The following provides a brief overview of the strategic acquisitions that we have completed since 2020.
During the second quarter of 2020, the Company acquired Synoste Oy, a Finnish engineering company that specializes in the research and development of a limb lengthening system.
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The NuVasive Merger expanded our global commercial reach, increased operational capabilities and enhanced our comprehensive offerings of Musculoskeletal Solutions and Enabling Technologies.
−Removed: During the first quarter of 2024, the Company completed a share acquisition of a biotechnology company focused on research and development for hemostasis solutions.
−Removed: We intend to selectively pursue acquisitions and alliances that complement our strategic plan and provide innovative technologies, personnel with significant relevant experience, or increased market penetration.
+Added: In 2024, we completed a share acquisition of a biotechnology company focused on research and development for hemostasis solutions.
+Added: In the second quarter of 2025, we acquired Nevro, a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in the treatment of chronic pain.
+Added: Nevro’s comprehensive HFX™ spinal cord stimulation (“SCS”) platform includes the Senza ® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.
+Added: Nevro also provides minimally invasive treatment options for patients suffering from chronic sacroiliac joint pain.
+Added: The Nevro Merger positions us to further add to our product portfolio with the potential to alter the standard of care in the neuromodulation space and beyond.
+Added: We intend to continue to selectively pursue acquisitions and alliances that complement our strategic plan and provide innovative technologies, personnel with significant relevant experience, or increased market penetration.
We regularly evaluate possible acquisitions and strategic relationships and believe that our resources and experience make us an attractive acquirer or partner.
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Musculoskeletal Solutions
−Removed: Our Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures.
+Added: Our Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, spinal cord stimulation treatment therapy, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures.
Musculoskeletal disorders are a leading driver of healthcare costs worldwide.
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Surgical treatments for musculoskeletal disorders can be instrumented, which include the use of implants, or non-instrumented, which forego the use of hardware but may include biologics.
+Added: Our spinal cord stimulation treatment therapy uses neuromodulation technology delivered by an implantable device that delivers electrical impulses to treat chronic pain.
+Added: Our neuromonitoring services use proprietary software-driven nerve detection and avoidance technology and include IONM services to aid spine surgery.
Our broad spectrum of spine products addresses the vast majority of conditions affecting the spine including degenerative conditions, deformity, tumors, and trauma.
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We believe we pioneered innovative expandable solutions for interbody fusion, corpectomy and interspinous fixation that allow intraoperative customization of our devices to the patient’s anatomy, eliminating sequential trialing and potentially saving surgical time.
−Removed: We have also developed treatment options for motion preservation technologies, such as dynamic stabilization, total disc replacement and interspinous distraction devices;
−Removed: as well as interventional solutions to treat vertebral compression fractures.
+Added: We have also developed treatment options for motion preservation technologies, such as dynamic stabilization, total disc replacement and interspinous distraction devices, as well as interventional solutions to treat vertebral compression fractures.
Our biologic solutions include regenerative biologic products such as allografts and synthetic alternatives that are adjunctive treatments typically used in combination with stabilizing implant hardware.
−Removed: Our orthopedic trauma solutions are designed to treat a wide variety of orthopedic fracture patterns and patient anatomies in the upper and lower extremities as well as the hip.
−Removed: Our orthopedic trauma and extremity products, covering four major segments of the orthopedic trauma market:
−Removed: fracture plates, compression screws, intramedullary nails, and external fixation.
+Added: Our orthopedic trauma solutions are designed to treat a wide variety of orthopedic fracture patterns and patient anatomies in the upper and lower extremities as well as the pelvis and hip.
+Added: Our orthopedic trauma portfolio spans core procedural categories including limb reconstruction, fracture plating, intramedullary nailing, external fixation, and compression screw technologies, anchored by the PRECICE™ limb reconstruction platform and the ANTHEM™ fracture plating system.
+Added: These offerings – supported by intramedullary nailing solutions for the hip, femur, and tibia, along with external fixation and cannulated screw technologies – form our ecosystem.
We began marketing these products in 2018 and intend to grow our presence in this field.
−Removed: Fracture plating includes proximal humerus, distal radius, proximal tibia, distal tibia, distal fibula, distal femur, small fragment, mini-fragment and clavicle plates.
−Removed: Intramedullary nailing includes tibial, trochanteric, and femoral nail systems.
−Removed: Regenerative biologic products such as bone void fillers and allograft struts are used in orthopedic procedures where applicable.
−Removed: Our hip and knee joint solutions for the treatment of degenerative conditions or failed previous reconstruction have a long history of clinical use.
−Removed: Over 16 different implants have been marketed to date, including modular hip stems and acetabular cups for total hip arthroplasty as well as posterior stabilizing and cruciate retaining knee arthroplasty implants.
+Added: Our hip and knee arthroplasty solutions for the treatment of degenerative conditions or failed previous reconstruction have a long history of clinical use.
+Added: We have marketed a variety of implants to date, including partial hip systems, primary hip systems, which include modular cemented and cementless hip stems, acetabular cups, femoral heads and highly cross-linked liners for hip arthroplasty, as well as partial knee systems, cruciate retaining, posterior stabilized, and revision options for knee arthroplasty.
+Added: Our spinal cord stimulation services for the treatment of chronic pain include the HFX™ SCS platform, featuring proprietary 10kHz Therapy™, for chronic back and limb pain, including conditions like failed back surgery syndrome, non-surgical refractory back pain, and painful diabetic neuropathy, providing non-pharmacological relief through advanced systems.
+Added: We provide patient support and physician tools, delivering high-frequency stimulation without paresthesia and supporting diverse therapies to better patient outcomes.
Our neuromonitoring services utilize proprietary software that employs hunting algorithms and graphical user interfaces to provide surgeons with an enhanced and intuitive nerve avoidance system.
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Our Enabling Technologies are comprised of imaging, navigation and robotics (“INR”) solutions for assisted surgery which are advanced computer-assisted intelligent systems designed to enhance a surgeon’s capabilities, and ultimately improve patient care and reduce radiation exposure for all involved, by streamlining surgical procedures to be safer, less invasive, and more accurate.
−Removed: The market for our Enabling Technologies in spine, cranial and orthopedic surgery is still in the infancy stage and consists primarily of imaging, navigation and robotic systems.
+Added: The market for our Enabling Technologies in spine, cranial and orthopedic surgery is still in the infancy stage and consists primarily of INR systems.
In spine, a majority of these technologies are limited to surgical planning and assistance in implant placement for increased accuracy and time savings with less intraoperative radiation exposure to the patient and surgical staff.
As our Enabling Technologies become more fully integrated with our Musculoskeletal Solutions, a continued rise in adoption is expected.
−Removed: Furthermore, we believe as new technologies such as augmented reality and artificial intelligence are introduced, Enabling Technologies have the potential to transform the way surgery is performed and most importantly, continue to improve patient outcomes.
+Added: Furthermore, we believe as new technologies are introduced, Enabling Technologies have the potential to transform the way surgery is performed and most importantly, continue to improve patient outcomes.
Our INR solutions include the ExcelsiusGPS ® platform, which is a robotic guidance and navigation system that supports minimally invasive and open procedures with screw and interbody spacer placement applications.
−Removed: The ExcelsiusGPS ® platform has a modular design that we expect will serve as a foundation for future clinical applications using artificial intelligence and augmented reality.
+Added: The ExcelsiusGPS ® platform has a modular design that we expect will serve as a foundation for future clinical applications using artificial intelligence (“AI”) and augmented reality.
Also, in 2018, we acquired Nemaris Inc., the company that developed and marketed Surgimap ® , a leading surgical planning software platform.
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In 2022, we launched Excelsius3D™, which when combined with the ExcelsiusGPS ® robotic navigation system, provides a superior intraoperative, image-guided robotic navigation solution that is designed to improve implant placement accuracy, lower radiation exposure, and shorten operative times.
−Removed: This highly maneuverable and intuitive imaging platform offers 3 imaging modalities, position memory, and a large field of view.
−Removed: In 2024, we launched the ExcelsiusHub® and the ExcelsiusFlex® to further expand our Excelsius® ecosystem.
+Added: This highly maneuverable and intuitive imaging platform offers three imaging modalities, position memory, and a large field of view.
+Added: In 2024, we launched the ExcelsiusHub ® and the ExcelsiusFlex ® .
The ExcelsiusHub ® provides real-time patient array monitoring, tissue sparing drills, and registration flexibility to elevate the safety of spine navigation.
The ExcelsiusFlex ® is a total knee arthroplasty robotic solution with imageless and computed tomography-based registration workflows.
−Removed: It was designed to give ergonomic control to the surgeon with enhanced feedback and visibility.
+Added: It was designed to give ergonomic control to the surgeon with enhanced feedback and visibilit y.
+Added: In 2025, we launched the ExcelsiusXR ® to further expand our Excelsius ® ecosystem.
+Added: The ExcelsiusXR ® is a wearable extended reality navigation headset designed to seamlessly blend visualization and control through a cockpit-like experience, to provide the surgeon with increased focus on the patient through enhanced ergonomics and uninterrupted workflows.
Our innovative Enabling Technologies products offer surgeons more information about patient anatomy and surgical options to help them to make well-informed preoperative and intraoperative surgical decisions.
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The markets in which we operate are subject to rapid technological advancements.
−Removed: We must constantly improve existing products and introduce new products in order to continue to succeed.
+Added: We must constantly improve existing products and introduce new products.
Accordingly, we have made significant investments in our product development and research capabilities.
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We expect to continue to increase the number of our direct and distributor sales representatives in each of these areas, both in the U.S.
−Removed: and internationally, to expand into new geographic territories and to deepen our penetration in existing territories.
+Added: internationally, to expand into new geographic territories and to deepen our penetration in existing territories.
We believe the expansion of our U.S.
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We believe that our significant competitors are Medtronic, DePuy Synthes, Stryker, Zimmer Biomet, and Smith + Nephew.
−Removed: Alphatec Holdings, Orthofix, Integra LifeSciences , ZimVie and other smaller public and private companies are also competitors of ours.
+Added: Alphatec Holdings, Orthofix, Integra LifeSciences , ZimVie, VB Spine, Boston Scientific and other smaller public and private companies are also competitors of ours.
At any time, these or other market participants may develop alternative treatments, products or procedures for the treatment of musculoskeletal disorders that compete directly or indirectly with our products.
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The Excelsius ® robotic systems are assembled in our facility in Methuen, Massachusetts.
+Added: Through the Nevro Merger our spinal cord simulation products such as the HFX™ SCS platform including the Senza ® SCS, are manufactured in our Costa Rica facility.
Of our implant and instrument products that are not manufactured in-house, a majority are generally manufactured through a network of third-party suppliers.
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Like our relationships with our device manufacturing suppliers, we subject our tissue processing suppliers to the same quality criteria in terms of selection, qualification, and verification of processed tissue quality upon receipt of goods, as well as hold them accountable for compliance with FDA regulations, state requirements, and voluntary industry standards (such as those put forward by the American Association of Tissue Banks).
−Removed: We also work with a limited number of suppliers for certain components of our Enabling Technologies and IONM platforms and continue to develop redundancies for critical components within those supply chains.
+Added: We also work with a limited number of suppliers for certain
+Added: components of our Enabling Technologies and IONM platforms and continue to develop redundancies for critical components within those supply chains.
Our quality assurance group conducts periodic audits to ensure continued compliance with our standards.
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Our receiving group also performs inspections, packaging and labeling at one of our facilities.
−Removed: We, and our third-party manufacturers, are subject to the quality system regulations of the FDA, state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union).
+Added: We, and our third-party manufacturers, are subject to the quality system regulations of the FDA, state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union (the “EU”)).
For tissue products, we are FDA-registered and licensed in the states of California, Delaware, Florida, Illinois, Maryland, New York, and Oregon.
For our device implants and instruments, we are FDA-registered, California-licensed, Conformité Européenne (“CE”)-marked and ISO-certified.
−Removed: CE, an acronym for “Conformité Européenne” or European Conformity, is the registration marking designating that a device can be commercially distributed throughout the European Union (“EU”).
−Removed: Our facilities and the facilities of our third-party manufacturers are subject to periodic announced and unannounced inspections by regulatory authorities, and may undergo compliance inspections conducted by the FDA, state, and/or international regulatory agencies for, among other things, conformance to Quality System Regulations and Current Good Manufacturing Practice requirements as well as separate foreign or international standards.
+Added: CE, an acronym for “Conformité Européenne” or European Conformity, is the conformity marking demonstrating that a device meets the necessary regulatory requirement and can be commercially distributed throughout the EU.
+Added: Our facilities and the facilities of our third-party manufacturers are subject to periodic announced and unannounced inspections by regulatory authorities and may undergo compliance inspections conducted by the FDA, state, and/or international regulatory agencies or equivalent bodies for, among other things, conformance to Quality System Regulations and Current Good Manufacturing Practice requirements as well as separate foreign or international standards.
We work closely with our suppliers to ensure that our inventory needs are met while maintaining high quality and reliability.
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Surgical Instrument, Implant Sets and Equipment Sales
−Removed: For many of our customers, we provide surgical instrumentation sets, including both implants and instruments, as well as our IONM systems in a manner tailored to fulfill our customer’s obligations to meet surgery schedules.
+Added: For many of our customers, we provide surgical instrumentation sets, including both implants and instruments, as well as our IONM systems in a manner tailored to fulfill our customers' obligations to meet surgery schedules.
We do not generally receive separate economic value specific to the surgical instrument sets from the surgeons or hospitals that utilize them.
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While this does not constitute a material component of our business, as customer penetration and volume increases, these sales of sets allow our customers to increase the amount of surgical volume performed locally.
−Removed: Additionally, we offer flexibility to customers for our capital equipment by offering capital sales and leasing arrangements.
−Removed: We do not have a long history of selling, leasing or servicing capital equipment, but we have invested and intend to continue to invest in building resources and expertise in this area.
−Removed: Selling and leasing of capital equipment do not make up a material portion of our total net sales.
+Added: Additionally, we offer flexibility to customers for our capital equipment within our Excelsius ® ecosystem by offering capital sales and leasing arrangements.
Intellectual Property
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Third-Party Coverage and Reimbursement
−Removed: We expect that sales volumes and prices of our Musculoskeletal Solutions products including spinal implant, orthopedic trauma, hip and knee arthroplasty, regenerative biologics, advanced technology products and IONM services may grow to be more dependent on the availability of coverage and reimbursement from third-party payors, such as state and federal programs including Medicare, Medicaid and workers’ compensation as well as private insurance plans including Blue Cross Blue Shield plans and commercial insurers.
+Added: We expect that sales volumes and prices of our Musculoskeletal Solutions products, including spinal implant, orthopedic trauma, hip and knee arthroplasty, regenerative biologics, advanced technology products, IONM services and spinal cord stimulation services, may grow to be more dependent on the availability of coverage and reimbursement from third-party payors, such as state and federal programs including Medicare, Medicaid and workers’ compensation, as well as private insurance plans including Blue Cross Blue Shield plans and commercial insurers.
Reimbursement is dynamic and is contingent on coding for given services or procedures, coverage by third-party payors, and adequate payment for the services or procedures.
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Reimbursement levels in the hospital outpatient and ambulatory surgery center settings are typically lower than for the hospital inpatient setting and may not be adequate to cover the cost of innovative and novel medical devices.
−Removed: In international markets, reimbursement and healthcare payment systems vary significantly by country and some countries have instituted price ceilings on specific product lines.
−Removed: There can be no assurance that our products will be accepted by third-party payors, that coverage and reimbursement will be available or, if available, that the third-party payors’ coverage and reimbursement policies will not adversely affect our ability to sell our products profitably.
+Added: In international markets, reimbursement and healthcare payment systems vary significantly by country and some countries have instituted price ceilings on specific product lines or other mechanism that may limit the profits that we can make from the sale of our products.
+Added: There can be no assurance that our products will be accepted by third-party payors, that coverage and reimbursement
+Added: will be available or, if available, that the third-party payors’ coverage and reimbursement policies will not adversely affect our ability to sell our products profitably.
In the U.S., as a result of healthcare reform, third-party payors are increasingly required to demonstrate they can improve quality and reduce costs;
−Removed: we accordingly see an increase in pre-approval/prior authorizations and non-coverage policies citing higher levels of evidence required for medical therapies and technologies.
+Added: accordingly, we see an increase in pre-approval/prior authorizations and non-coverage policies citing higher levels of evidence required for medical therapies and technologies.
In addition, insured individuals are facing increased premiums and higher out–of-pocket costs for medical coverage, which may lead patients to delay medical treatment.
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We discuss below the statutes and regulations that are most relevant to our business.
−Removed: There may be future changes in legal and regulatory requirements that may materially impact our results of operations.
−Removed: Future changes in legal and regulatory requirements may introduce new risks into our operations and future prospects, which we are not able to currently anticipate.
−Removed: For example, changes taking place in the U.S.
−Removed: associated with a new federal administration, as well as changes in legal standards, including the reduced level of deference due to administrative agencies, such as the FDA, following a 2024 Supreme Court decision, may introduce uncertainties with respect to our current and future operations and our future likelihood of success.
−Removed: It is possible that new federal or state laws or regulations may be passed, or laws and regulations may be enforced differently than they were before, which may expose us to additional legal and regulatory risk or uncertainty and require the expenditure of additional resources to ensure that we are able to comply.
−Removed: Such actions could also adversely restrict our business and operations.
−Removed: There could also be changes in the federal workforce and agency policies that may result in regulatory delays, including with respect to the FDA’s review of medical device marketing applications and other submissions, and that may impact the ability to communicate with and obtain guidance from the agencies.
−Removed: At this time, it is too early to predict the exact nature of any changes that may take place or whether and how they may impact our business and results of operations.
Food and Drug Administration Regulation
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Unless an exemption applies (as is usually the case with instruments not intended for implantation), each medical device we wish to introduce within interstate commerce in the U.S.
−Removed: requires pre-authorization by the FDA either via 510(k) clearance, premarket approval (“PMA”), grant of a de novo classification request grant or, in less frequent occasions, via Humanitarian Device Exemption (“HDE”) approval.
−Removed: The FDA classifies medical devices into three classes and devices deemed to pose low or moderate risk are placed in either Class I or II.
−Removed: Unless determined as exempt from premarket notification, Class I and II devices generally require the manufacturer to submit to the FDA a premarket notification seeking permission for commercial distribution, and detailing substantial equivalence to another legally U.S.
−Removed: marketed medical device.
−Removed: This process is known as 510(k) review and if successfully resolved results in issuance of a 510(k) clearance by the FDA.
−Removed: The FDA has identified low risk devices which are exempt from this pre-authorization requirement but are not exempt from Design Controls (compliance to which must be documented internally).
−Removed: Devices deemed by the FDA to pose the greatest risk to patients, such as life-sustaining, life-supporting or implantable devices, and devices deemed not substantially equivalent to a previously cleared 510(k) devices are designated as Class III, which typically requires approval of a PMA application.
−Removed: For novel/unclassified devices not previously formally classified by the FDA with no legally marketed predicate which present low to moderate risk, a risk-based classification determination can be requested in accordance with the de novo classification request process, under which the FDA may determine that the product can be appropriately regulated as a Class I or II device and “granted” authorization for commercialization within the U.S.
−Removed: For novel/unclassified devices not previously formally classified by the FDA with no legally marketed predicate intended to treat or diagnose a disease or condition that affects fewer than 8,000 individuals per year in the U.S., the FDA requires adherence to the HDE program.
−Removed: This requires a Humanitarian Use Designation (“HUD”);
−Removed: if the FDA approves the HUD, manufacturers should then seek FDA approval on an Investigational Device Exemption (“IDE”) to collect the necessary human clinical data to support approval of the HDE application.
+Added: requires pre-authorization by the FDA either via 510(k) clearance, premarket approval (“PMA”), de novo classification request grant or, in less frequent occasions, via Humanitarian Device Exemption (“HDE”) approval.
+Added: The FDA classifies medical devices into three classes based on risk, with devices deemed to pose low or moderate risk are placed in either Class I or II, respectively.
+Added: Unless determined as exempt from premarket notification, Class I and II devices generally require the manufacturer to submit to the FDA a 510(k) premarket notification seeking permission for commercial distribution.
+Added: The FDA will clear the 510(k) notification if the device manufacturer demonstrates that the subject device is, substantially equivalence to another legally U.S.
+Added: marketed medical device, known as a “predicate device”.
+Added: If a manufacturer cannot establish that a new or modified product is substantially equivalent to a predicate device, the 510(k) notification will be rejected, and the manufacturer may be required to seek premarket approval through the PMA or de novo process (as discussed below).
+Added: The FDA has exempted certain low risk Class I and II devices from this 510(k) pre-authorization requirement.
+Added: Those Class II devices that are 510(k)-exempt remain subject to the premarket requirements for Design Controls (compliance to which must be documented internally);
+Added: however, most Class
+Added: I devices are exempt from Design Controls (with limited exemptions).
+Added: Devices deemed by the FDA to pose the greatest risk to patients, such as life-sustaining, life-supporting or implantable devices are designated as Class III, which typically requires approval of a PMA application.
+Added: A PMA application is the most burdensome type of medical device application, requiring the manufacturer to demonstrate the device is safe and effective for its intended use and typically requires conduct and submission of human clinical trials with high costs and uncertain outcomes.
+Added: Novel/unclassified devices not previously formally classified by the FDA with no legally marketed predicate are considered Class III by default.
+Added: If such a novel device presents low to moderate risk, a risk-based classification determination can be requested through the de novo classification request process, under which the FDA may determine that the product can be appropriately reclassified as a Class I or II device and “granted” authorization for commercialization within the U.S.
+Added: For devices intended to treat or diagnose a rare disease or condition that affects fewer than 8,000 individuals per year in the U.S., to the device manufacturer may seek approval under the HDE program, which is a two-step process.
+Added: For the first step, the device manufacturer must submit a request for Humanitarian Use Device (“HUD”) Designation for its device.
+Added: The HUD request must include, among other things, information on the rare disease or condition the device is intended to treat or diagnose and a scientific rationale for the use of the device for the rare disease or condition.
+Added: If the FDA approves the HUD request, the manufacturer may then submit an HDE application.
+Added: In some cases, data from clinical studies on human subjects is necessary to support a 510(k) notification, de novo , PMA, or HDE application.
+Added: Not all 510(k) notifications require clinical data, but many de novo applications and most PMA and HDE applications do.
+Added: Clinical studies on medical devices must be performed in compliance with the FDA’s Investigational Device Exemption (“IDE”) regulations.
+Added: The IDE regulations include requirements for informed consent, review and oversight by an Institutional Review Board (“IRB”), investigational device labeling, clinical study monitoring, record-keeping, and reporting.
+Added: For studies involving a “significant risk” device (as defined by FDA regulation), the study sponsor also must submit an IDE application to the FDA before the study can begin.
510(k) premarket notifications, de novo requests, and PMAs are subject to the payment of user fees, paid at the time of submission for FDA review.
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continued follow-up of enrolled / implanted investigational patients, periodic annual clinical reporting, site monitoring and oversight of on-going Institutional Review Board compliance.
−Removed: Since the Institute of Medicine published their review of the predicated 510(k) review process in 2010, the FDA has continually worked to strengthen and modernize the 510(k) Program.
−Removed: The FDA continues to improve the program through policies which clarify the FDA’s expectations for the content of filings, establishment of alternative pathways to a Traditional 510(k) (known as the Safety and Performance Based pathway), and through the issuance of numerous draft guidance.
−Removed: This evolution has impacted the ability of medical device manufacturers to obtain or maintain 510(k) clearance for devices by both driving clarity and incentivizing the development of safer, more effective devices.
−Removed: Manufacturers must continue to demonstrate their product’s same / superior performance to existing devices more readily & extensively.
−Removed: Among other initiatives, the FDA promotes the use of a best-practice approach as it relates to predicate devices with a long-established history of safe and effective use as opposed to simply accepting reliance on older predicate devices for purposes of comparison in new device 510(k) clearance submissions.
−Removed: If a manufacturer cannot establish that a new or modified product is substantially equivalent to a predicate device, it may be required to seek premarket approval through the PMA or de novo process (the latter only for new products).
−Removed: There are numerous increased burdens associated with the PMA process, which typically requires conduct and submission of human clinical trials with high costs and uncertain outcomes.
+Added: The Senza SCS system is a Class III device subject to review and approval through the PMA pathway.
+Added: PMA applications must be supported by, among other things, valid scientific evidence, which typically requires extensive data, including technical, preclinical, clinical and manufacturing data, to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device.
+Added: A PMA application must also include, among other things, a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device and proposed labeling.
+Added: Approval by the FDA of new PMA applications or PMA supplements may be required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that is approved through the PMA process.
+Added: Certain other changes to an approved device also require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.
+Added: PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application and may not require as extensive clinical data.
FDA Postmarket Requirements
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• device listing and establishment registration;
−Removed: adherence to the Quality System Regulation (per 21 CFR Part 820) (“QSR”) and the newly published Quality Management System Regulation (effective February 2, 2026) which requires stringent design, testing, control, documentation and other quality assurance procedures;
+Added: • adherence to the Quality Management System Regulation (per 21 CFR Part 820) (“QMSR”), which requires stringent design, testing, control, documentation and other quality assurance procedures;
• labeling requirements and FDA prohibitions against the promotion of off-label uses or indications;
−Removed: adverse event reporting (Manufacturer and User Facility Device Experience);
+Added: • unique device identification (UDI) requirements;
+Added: • adverse event reporting (Medical Device Reporting, or “MDR”);
• post-approval restrictions or conditions, which could include post-approval clinical trials or other required testing and periodic reporting;
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• the FDA’s recall authority, whereby it can ask for, or require, the recall of products from the market (see FDA Enforcement section below);
−Removed: requirements relating to voluntary corrections or removals.
+Added: • requirements relating to voluntary corrections or removals, including reporting to the FDA for such corrections and removals.
Failure to comply with applicable regulatory requirements can result in fines and other enforcement actions by the FDA, which could adversely impact our business.
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The FDA regulates human tissue products as Human Cells and Cellular and Tissue-Based Products (“HCT/Ps”).
−Removed: Certain HCT/Ps are regulated solely under Section 361 of the Public Health Service Act and are referred to as “Section 361 HCT/Ps,” while other HCT/Ps are subject to the FDA’s regulatory requirements for medical devices or biologics under 21 CFR Parts 1270 and 1271.
+Added: Certain HCT/Ps are regulated solely under Section 361 of the Public Health Service Act and are referred to as “Section 361 HCT/Ps,” while other HCT/Ps are subject to the FDA’s regulatory requirements for medical devices or biologics in addition to the regulatory requirements under 21 CFR Parts 1270 and 1271.
Section 361 HCT/Ps do not require premarket authorization (510(k) clearance, PMA approval, or other pre-market approvals) from the FDA before marketing.
−Removed: Tissue banks that handle HCT/Ps must register their establishments with the FDA, list their HCT/P products with the FDA, and comply with FDA donor eligibility and screening requirements, current Good Tissue Practice (“CGTP”), Cellular- and Tissue-Based Product Establishments , product labeling, and postmarket reporting requirements for HCT/Ps.
+Added: Tissue banks that handle HCT/Ps must register their establishments with the FDA, list their HCT/P products with the FDA, and comply with FDA donor eligibility and screening requirements, current Good Tissue Practice (“CGTP”), product labeling requirements, and postmarket reporting requirements for HCT/Ps.
The FDA and other state and regional agencies periodically inspect tissue processors to determine compliance with these requirements.
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• untitled letters or formal warning letters;
+Added: • import alerts;
• fines, injunctions and civil penalties;
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• operating restrictions, partial suspension or total shutdown of production;
−Removed: refusing our request for review of 510(k), de novo, or PMA of new products;
−Removed: withdrawal of 510(k) clearance(s), de novo grant(s), or PMA approval(s) that are already issued;
+Added: • refusing our request for review of 510(k), de novo , PMA or HDE applications for new or modified products;
+Added: • withdrawal of 510(k) clearance(s), de novo grant(s), PMA or HDE approval(s) that are already issued;
• refusal to grant export approval of our products;
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The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance, approval or grant, and the requirements may differ.
−Removed: The EU/European Economic Area (“EEA”) requires a CE mark in order to place medical devices “in market”.
−Removed: Many other countries, such as Australia, India, New Zealand, Pakistan and Sri Lanka, accept CE or FDA authorizations (clearance, approval or grant).
+Added: The EU/European Economic Area (“EEA”) requires a CE mark in order to place medical devices “on the market”.
+Added: Many other countries, such as Australia, India, New Zealand, Pakistan and Sri Lanka, accept, or recognize CE or FDA authorizations (clearance, approval or grant) in certain circumstances.
Other countries, such as Brazil, Canada, Switzerland and Japan, require separate region-specific regulatory filings.
−Removed: In the EEA, our devices are required to comply with the essential requirements of the EU Medical Device Directive (Council Directive 93/42/EEC) (“MDD”).
+Added: In the EEA, the EU has adopted the EU Medical Device Regulation 2017/745 (“MDR”), which replaces the previous EU Medical Device Directive (Council Directive 93/42/EEC) (“MDD”), and imposes stricter requirements for marketing and sale of our medical devices, including new clinical evaluation, quality systems, and post-market surveillance requirements.
Compliance with these requirements entitles us to affix the CE conformity mark to our medical devices, without which medical devices cannot be commercialized in the EEA.
−Removed: To demonstrate compliance with the essential requirements and obtain the right to affix the CE conformity mark we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
+Added: To demonstrate compliance with the relevant requirements and obtain the right to affix the CE conformity mark we must undergo a conformity assessment procedure, which varies according to the type of medical device and its risk classification.
The method of assessing conformity varies depending on the classification of the product, but typically involves a combination of self-assessment by the manufacturer and a third-party assessment by an accredited “Notified Body”.
This third-party assessment consists of an audit of the manufacturer’s quality system and technical review of the manufacturer’s product.
−Removed: The EU has also adopted the EU Medical Device Regulation 2017/745 (“MDR”), which replaced existing directives and imposes stricter requirements for the marketing and sale of medical devices, including new clinical evaluation, quality system, and post-market surveillance requirements.
−Removed: Following the expiration of the transitional provisions of the MDD relating to the CE mark (extended to December 2027 or December 2028 depending on product classification), all medical device companies intending to manufacture and/or market products in the EEA after May 2024, including Globus Medical, NuVasive and NuVasive Specialized Orthopedics), will be required to comply with requirements of the MDR, which increased technical documentation requirements, imparted more labeling obligations of higher risk devices, and altered the classification of some of our products.
−Removed: Most devices that are CE-marked under the MDD may continue to be marketed in the EU under certain conditions until December 2027 for Class III and IIb implantable devices;
+Added: All medical device companies intending to manufacture and/or market products in the EEA (including Globus), will be required to comply with requirements of the MDR, which increased technical documentation requirements, imparted more labeling obligations of higher risk devices, and altered the classification of some of our products.
+Added: However, given the increase in the requirements and transition provisions that have been put in place, most devices that are CE-marked under the previous MDD may continue to be marketed in the EU under certain conditions until December 2027 for Class III and IIb implantable devices;
2028 for other Class IIb, IIa and Class I devices which require involvement of a Notified Body in the conformity assessment, at which time these products must comply with the MDR.
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Additionally, in the EEA, the procurement, testing, processing, preservation, storage and distribution of human tissues and cells is subject to the requirements of the laws of individual EEA Member States implementing Directive 2004/23/EC, Directive 2006/17/EC and Directive 2006/86/EC.
−Removed: Further, the advertising and promotion of our products in the EEA is subject to limited provisions under MDR and the laws of individual EEA Member States implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws and industry codes governing the advertising and promotion of medical devices.
−Removed: These laws and codes may limit or restrict the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.
+Added: In May 2024, a new regulation 2024/1938/EU was adopted on substances of human origin that seek to harmonize the requirements across the EU.
+Added: Further, the advertising and promotion of our products in the EEA is subject to limited provisions under the MDD, MDR, and the laws of individual EEA Member States implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws and industry codes governing the advertising and promotion of medical devices.
+Added: These laws and codes may limit or restrict the advertising and promotion of our products to the general public in certain countries and may impose limitations on our promotional activities with healthcare professionals.
In addition to the presiding MDD and MDR outlined above, we must also comply with EU / EEA laws, directives, regulations and recognized standards as applicable to the devices we produce.
−Removed: These requirements can include all facets of healthcare, including environmental compliance, product stewardship, technical considerations, material of manufacture, and labeling availability.
−Removed: Below is a non-exhaustive list of requirements to apply to devices within our portfolio and to which we must demonstrate some degree of compliance:
+Added: These requirements can include all facets of healthcare,
+Added: including environmental compliance, product stewardship, technical considerations, material of manufacture, and labeling availability.
+Added: Below is a non-exhaustive list of requirements that apply to devices within our portfolio and to which we must demonstrate some degree of compliance (each as may be amended by the relevant authorities from time to time):
• Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals;
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• Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.
−Removed: In addition to compliance with EU & EEA statutes, we must also comply with national laws of individual sovereign nations (i.e.
−Removed: Member States).
−Removed: These laws vary and can include additional registration efforts to be completed before CE -marked product can be distributed within respective Member States.
−Removed: Following a national referendum and enactment of legislation by the government of the United Kingdom (“UK”), the UK formally withdrew from the EU and ratified a trade and cooperation agreement governing its future relationship with the EU.
+Added: In addition to compliance with these statutes, we must also comply with national laws of individual sovereign nations (i.e.
+Added: Member States), in particular relation to supply and distribution within respective Member States, or national rules that may implement the above EU-wide legislation.
+Added: Following a national referendum and enactment of legislation by the government of the United Kingdom (“UK”), the UK formally withdrew from the EU and ratified a trade and cooperation agreement with the EU governing its future relationship with the EU.
The agreement addresses trade, economic arrangements, law enforcement, judicial cooperation, and a governance framework, including procedures for dispute resolution, among other things.
−Removed: Because the agreement merely sets forth a framework in many respects and will require complex additional bilateral negotiations between the UK and the EU, significant political and economic uncertainty remains about how the precise terms of the relationship between the parties will differ from the terms before withdrawal.
−Removed: Further, pursuant to guidance issued by the UK Government, the Medicines and Healthcare products Regulatory Agency (“MHRA”) became the standalone medicines and medical devices regulator for the UK as of January 1, 2021.
−Removed: A new mark, UK Conformity Assessed (“UKCA”), has also been introduced and will replace the CE conformity mark in the UK.
−Removed: UK-approved Notified Bodies designated by the MHRA will conduct conformity assessments against applicable requirements of the UKCA mark.
−Removed: Obtaining the UKCA conformity mark is optional from January 2021 and will have rolling requirements for MDD/MDR certified devices until June 30, 2030.
−Removed: Although CE conformity marking and certificates issued by Notified Bodies will continue to be recognized in the UK until June 30, 2028 for medical devices that have undergone the conformity procedure under the EU MDD and until June 30, 2030 for medical devices that have undergone the conformity procedure under the EU MDR, all medical devices are required to be registered with the MHRA as of January 1, 2021 in accordance with the provided grace period depending on the product risk classification.
−Removed: Additionally, for manufacturers based outside of the UK, a single UK Responsible Person with a place of business in the UK must be established.
+Added: Because the agreement merely sets forth a framework in many respects and the regulatory framework for medical devices is set out in a range of legislative instruments, some of which are based on EU legislation, significant uncertainty remains about how the regulatory framework in the UK will evolve and differ from the terms before withdrawal and the position in the EU.
+Added: Further, the Medicines and Healthcare products Regulatory Agency (“MHRA”) became the standalone medicines and medical devices regulator for the UK as of January 1, 2021.
+Added: A new mark, UK Conformity Assessed (“UKCA”), has been introduced.
+Added: UK Approved Bodies, equivalent to Notified Bodies (an organization accredited by a Member State of the EEA to conduct conformity assessments) in the EU, designated by the MHRA will conduct conformity assessments against ap plicable requirements of the UKCA mark.
+Added: Obtaining the UKCA conformity mark is optional from January 2021 and the new UK legislative framework for medical devices has not yet been finalized.
+Added: However, CE conformity marking and certificates issued by Notified Bodies will continue to be recognized in the UK until June 30, 2028 for medical devices that have undergone the conformity procedure under the EU MDD and until June 30, 2030 for medical devices that have undergone the conformity procedure under the EU MDR, and the MHRA is conducting a consultation on whether this recognition should continue indefinitely.
+Added: In addition, all medical devices are required to be registered with the MHRA as of January 1, 2021 in accordance with the provided grace period depending on the product risk classification and for manufacturers based outside of the UK, a single UK Responsible Person with a place of business in the UK must be established.
Complying with this new regulatory framework will require us to invest in additional resources and could be expensive, time-consuming and disruptive to our existing operations in the UK.
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Device and tissue pre-market approval, registration.
−Removed: and facility licensing requirements also exist in other markets where international facilities are established and where we may conduct business, including, but not limited to, Southeast Asia, Australia, and Latin America.
+Added: and facility licensing requirements also exist in other markets where international facilities are established and where we may conduct business, including, but not limited to, Southeast Asia, Australia, and
+Added: Latin America.
Such requirements vary by country and Globus Medical & all its subsidiaries have established procedures to drive its compliance with these requirements.
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These data protection regulations create a range of compliance obligations and authorize substantial fines for non-compliance.
−Removed: We are subject to announced and unannounced device inspections by Notified Bodies (an organization accredited by a Member State of the EEA to conduct conformity assessments), as well as other regulatory agencies overseeing the implementation and adherence of applicable regulations.
+Added: We are subject to announced and unannounced device inspections by Notified Bodies, as well as other regulatory agencies overseeing the implementation and adherence of applicable regulations.
These inspections may include our suppliers’ facilities.
Sales and Marketing Commercial Compliance
−Removed: Federal anti-kickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for, to induce or to reward either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs.
+Added: federal Anti-Kickback Statute and its implementing regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for, to induce or to reward either the referral of an individual, or the purchase, order or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs.
The term “remuneration” has been interpreted broadly to include anything of value.
+Added: There are certain statutory exceptions and regulatory safe harbors protecting some common activities from prosecution.
+Added: The exceptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.
+Added: Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.
+Added: Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of the facts and circumstances.
+Added: Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare program business, including purchases of products paid by federal healthcare programs, the statute has been violated.
+Added: The Affordable Care Act (the “ACA”) modified the intent requirement under the Anti-Kickback Statute to a stricter standard, such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
+Added: The ACA also provided that a violation of the federal Anti-Kickback Statute is grounds for the government or a whistleblower to assert that a claim for payment of items or services resulting from such violation is a per se false or fraudulent claim for purposes of the federal civil False Claims Act (“FCA”).
State anti-kickback laws have similar prohibitions.
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or knowingly avoiding, decreasing or concealing an obligation to pay money to the federal government.
+Added: A claim includes “any request or demand” for money or property presented to the U.S.
Violations of the federal Anti-Kickback Statute and off-label promotion have been pursued by the Department of Justice (the “DOJ”) and the Department of Health and Human Services (“HHS”) as violations of the FCA.
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Relators are incentivized to pursue claims against manufacturers and providers by the potential to share in any monetary recoveries by the government in litigation or as part of a settlement, which can be significant.
+Added: The civil FCA provides for treble damages and a civil penalty for each false claim, such as an invoice or pharmacy claim for reimbursement, which can aggregate into hundreds of millions of dollars.
+Added: Judgment for violating the civil FCA may result in exclusion from participation in federal health care programs, suspension and debarment from government contracts, and refusal of orders under existing government contracts.
In addition, private payers have been filing follow-on lawsuits alleging fraudulent misrepresentation, although establishing liability and damages in these cases is more difficult than under the FCA.
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Legislation periodically is introduced in the United States Congress that would broaden the applicability of the FCA and implement other changes that would not be favorable to defendants in FCA cases.
−Removed: If enacted, such legislation could apply to any case filed under the FCA on or after the date of enactment.
+Added: If enacted, the government and Relators could assert that such legislation applies to any pending FCA cases, even those filed under prior to the date of enactment.
Additionally, the majority of states in which we market our products have similar anti-kickback, false claims, anti-fee splitting and physician self-referral laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and violations may result in substantial civil and criminal sanctions.
−Removed: Other federal statutes pertaining to healthcare fraud and abuse include the civil monetary penalties statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), which prohibits, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare benefits, items or services.
+Added: Other federal statutes pertaining to healthcare fraud and abuse include the civil monetary penalties statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), which prohibits, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud or
+Added: to obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program, regardless of whether the payor is public or private, in connection with the delivery of or payment for healthcare benefits, items or services.
Also under HIPAA, a Covered Entity is required to adhere to certain requirements regarding the use, disclosure and security of protected health information (“PHI”).
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The Physician Payments Sunshine Act of 2009 (the “Sunshine Act”) was enacted into law in 2010 and requires public disclosure to the U.S.
−Removed: government of certain payments and other transfers of value to U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and nurse midwives, and to U.S.
+Added: government of certain payments and other transfers of value to U.S.-licensed physicians (defined to include doctors of medicine and osteopathy, dentists, optometrists, podiatrists, and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse-midwives, and to U.S.
teaching hospitals, including in-kind transfers of value such as educational items or meals.
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The Sunshine Act requires that we file an annual report on March 31 of a calendar year for the payments and other transfers of value incurred for the prior calendar year.
−Removed: This law, along with various international and individual state reporting, compliance program, gift ban and marketing program requirements, such as in Massachusetts and Vermont, increases the possibility that a healthcare company may run afoul of one or more of the requirements.
+Added: This law, along with applicable individual state reporting, compliance programs, gift ban and marketing program requirements, such as in Massachusetts and Vermont, increases the possibility that a company may run afoul of one or more of the requirements.
+Added: Also, we must comply with a variety of other laws outside of the U.S.
+Added: that impose extensive tracking and reporting requirements related to transfers of value provided to certain healthcare professionals.
Foreign Corrupt Practices Act (“FCPA”) and similar anti-bribery laws in non-U.S.
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are with governmental entities and are therefore potentially subject to such laws.
−Removed: Global enforcement of anti-corruption laws has increased considerably in recent years, with more frequent voluntary self-disclosures by companies, aggressive investigations and enforcement proceedings by U.S.
+Added: Notwithstanding initial announcements by the current U.S.
+Added: administration regarding FCPA enforcement priorities global enforcement of anti-corruption laws has increased considerably in recent years, with more frequent voluntary self-disclosures by companies, aggressive investigations and enforcement proceedings by U.S.
governmental agencies, and assessment of significant fines and penalties against companies and individuals.
It is our policy to implement safeguards to educate our employees and agents on these legal requirements and prohibit improper practices.
−Removed: The government may seek to hold us liable for FCPA violations committed by companies that we acquire.
−Removed: Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment of current or former employees, and exclusion from participation in governmental healthcare programs.
−Removed: Additionally, we must comply with a variety of other laws that protect the privacy of individually identifiable healthcare information and impose extensive tracking and reporting related to transfers of value provided to certain healthcare professionals.
+Added: The government may seek to hold us liable for FCPA violations committed by companies that we acquire and by certain of our vendors, contractors, and agents, including our independent distributors.
+Added: Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, penalties, imprisonment of current or former employees, and exclusion from participation in governmental healthcare programs.
Environmental Matters
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As of December 31, 2025, we had over 6,000 employees worldwide, including sales and marketing, product development, operations, general administrative and accounting, both domestically and internationally.
−Removed: Except for one market outside the U.S.
+Added: Except for one market outside of the U.S.
where employees are subject to a collective bargaining agreement, our workforce is not unionized.
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We are committed to providing competitive compensation and benefits to support our employees as they contribute to our mission of becoming the global leader in musculoskeletal technology.
−Removed: Our comprehensive benefits package includes:
+Added: Our comprehensive benefits package for eligible employees includes:
• Competitive pay and annual incentive awards;
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To achieve this goal, we devote time and resources to assist our employees in being familiar with our business, industry, and product offerings.
−Removed: We have developed a robust onboarding program for our newly hired associates that provides a comprehensive overview of our product portfolio and company history.
+Added: We have developed a robust onboarding program for our newly-hired employees that provides a comprehensive overview of our product portfolio and Company history.
We put an emphasis on training our employees and sales representatives to understand our business, including the underlying medical conditions that our products treat.
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To support long-term growth, we encourage employees to partner with their managers to create Individual Development Plans tailored to their career aspirations.
−Removed: In 2024, we launched two training platforms designed to enhance skills for individual contributors and to develop current and emerging leaders.
+Added: We continue to offer training programs for current leaders and to develop emerging talent, both in leadership roles and as individual contributors.
These programs reinforce our commitment to talent development and to providing opportunities for employees to achieve their career goals.
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Our success depends on our employees understanding our strategy, as well as our annual goals and priorities.
−Removed: This is accomplished through a number of channels, including a global intranet and sales enablement platform, regional and functional meetings, and quarterly
−Removed: updates in global Town Halls with leadership.
+Added: This is accomplished through a number of channels, including a global intranet and sales enablement platform, regional and functional meetings, and quarterly updates in global Town Halls with leadership.
We value open and direct communication with our employees about their experiences.
−Removed: We use a variety of channels to obtain employee feedback, including open forums with leadership, and an employee resource group.
+Added: We use a variety of channels to obtain employee feedback, including open forums with leadership.
Each year, the input received through these mechanisms is used to help strengthen our culture and improve employee engagement.
−Removed: Diversity and Inclusion
−Removed: We recognize the value associated with fostering a work environment that is diverse and inclusive and believe that diverse teams stimulate innovation, enhance our understanding of the needs of our customers, and ultimately deliver better results for our stakeholders.
+Added: We recognize the value associated with fostering a work environment that is inclusive and believe that varied backgrounds and experiences stimulate innovation, enhance our understanding of the needs of our customers, and ultimately deliver better results for our stakeholders.
Our goal is to cultivate a respectful and professional environment where all voices are heard and valued.
Our HR and talent teams actively support professional development opportunities for employees across all demographics.
−Removed: We monitor voluntarily disclosed diversity data to track progress in hiring, promotion, and attrition and ensure fairness in performance evaluations, promotions, and compensation.
−Removed: By building diverse teams and leveraging broad perspectives, we strengthen our ability to meet the needs of our customers, patients, and communities.
Health, Safety, and Wellness
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• Conduct training programs and annual safety campaigns;
−Removed: Monitor compliance to reduce and ultimately eliminate serious injuries
+Added: • Monitor compliance to reduce and ultimately eliminate serious in juries.
Our programs also emphasize corporate compliance, recycling, hazardous waste management, and emergency preparedness.
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In addition, through our grants program, we support medical research and education, charitable and philanthropic endeavors.
−Removed: Our employee resource group, Globus Women’s Network, contributes to charitable causes, including shelters, food banks, and breast cancer research.
+Added: We contribute to charitable causes, including shelters, food banks, and breast cancer research.
We are proud to operate responsibly and prioritize community engagement as part of our broader mission.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.