What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-04 compared with 2025-03-05 · 93 added, 80 removed, 636 unchanged (21% of the section changed)

6 unchanged sentences

was converted to a Delaware corporation on November 30, 2007.

We sell our specialized products, including PediLoc ® , PediPlates ® , Cannulated Screws, PediFlex TM nail, PediNail TM , PediLoc ® Tibia, ACL Reconstruction System, Locking Cannulated Blade, Locking Proximal Femur, Spica Tables, RESPONSE TM Spine, BandLoc TM , Pediatric Nailing Platform | Femur, Devise Rail, Orthex ® , The Fassier-Duval Telescopic Intramedullary System ® , SLIM TM Nail, The GAP Nail TM , The Free Gliding SCFE Screw System TM , GIRO ™ Growth Modulation System, PNP Tibia System, ApiFix ® Mid-C System, Mitchell Ponseti ® and Boston Brace 3D ® specialized bracing products to various hospitals and medical facilities throughout the United States and various international markets.

We currently use a contract manufacturing model for the manufacturing of implants and related surgical instrumentation while our orthopedic bracing products are manufactured in-house.

We sell our specialized products, including PediLoc ® , PediPlates ® , Cannulated Screws, PediFlex TM nail, PediNail TM , PediLoc ® Tibia, ACL Reconstruction System, Locking Cannulated Blade, Locking Proximal Femur, Spica Tables, RESPONSE TM Spine, BandLoc TM , Pediatric Nailing Platform | Femur, Devise Rail, Orthex ® , The Fassier-Duval Telescopic Intramedullary System ® , SLIM TM Nail, The GAP Nail TM , The Free Gliding SCFE Screw System TM , GIRO ™ Growth Modulation System, PNP Tibia System, ApiFix ® Mid-C System, Mitchell Ponseti ® , VerteGlide TM , and Boston Brace 3D ® specialized bracing products to various hospitals and medical facilities throughout the United States and various international markets.

We currently use a contract manufacturing model for the manufacturing of implants and related surgical instrumentation while our orthopedic bracing products are typically manufactured in-house.

We also operate multiple orthotic and prosthetic ("O&P") clinics delivering leading pediatric non-surgical O&P treatment.

5 unchanged sentences

In February 2024, we opened a warehouse in Australia and hired operating and sales representatives.

In July 2025, we opened a warehouse in the Netherlands.

In November 2025, we established a legal entity in Brazil to sell and distribute directly to the local market.

The Company routinely explores opportunities to acquire or invest in complementary products, technologies or businesses.

5 unchanged sentences

Boston O&P has developed and manufactures pediatric orthotic and prosthetic devices, including non-surgical scoliosis treatment options, and provides related clinical services.

In 2024, Boston O&P completed an acquisition of substantially all of the assets, including inventory, related to orthotic and prosthetic device clinics located in Virginia and Maryland.

In 2024, Boston O&P completed acquisitions of substantially all of the assets, including inventory, related to orthotic and prosthetic device clinics located in Virginia and Maryland.

Boston O&P also purchased all issued and outstanding share capital of clinics in Florida as well as multiple clinics in Colorado.

In 2025, Boston O&P completed acquisitions of substantially all of the assets, including inventory, related to orthotic and prosthetic device clinics located in North Carolina, Colorado, and New York.

Boston O&P also purchased all issued and oustanding share capital of clinics in Florida and Connecticut.

In 2025, OP EU B.V., a wholly-owned Netherlands based subsidiary of the Company, purchased all of the issued and outstanding share capital related to orthotic and prosthetic device clinics located in Ireland.

In 2025, OrthoPediatrics EU Limited, a wholly-owned UK based subsidiary of the Company, purchased all of the issued and outstanding share capital of a designer and manufacturer of clubfoot bracing located in the UK.

In 2025, Orthopediatrics do Brasil Ltda., a wholly-owned Brazil based subsidiary of the Company, purchased all of the issued and outstanding share capital of a local distributor.

In addition to acquisitions, we also look for partnerships which can provide us with complementary enabling technologies.

For example, in 2021 we extended our license agreement for our exclusive distribution rights of the FIREFLY ® Technology.

In 2025, the license agreement was amended and extended until 2030.

Also in 2021, we entered into a license agreement resulting in exclusive distribution rights of the 7D Surgical FLASH TM Navigation platform for pediatric applications.

In 2025, this license agreement was extended through 2028.

In 2023, we entered into a license agreement with Ora Medical resulting in exclusive distribution rights of the Levity gait assist device.

In 2024, we entered into a license and supply agreement with Innovation Lab to bring the Move-D tm brace to market.

partnerships allow for exclusive distribution in children's hospitals across the United States and serve as supporting avenues for us to focus on high-volume children's hospitals.

On August 15, 2022, we raised net proceeds of approximately $139.3 million from a public offering of (a) 1,091,250 shares our common stock, and (b) pre-funded warrants exercisable for an aggregate of up to 1,525,000 shares of common stock to Squadron Capital LLC (“Squadron”), our largest investor.

The net proceeds reflect the Company’s payment of $4.3 million in underwriting discounts and commissions and $0.3 million in other offering costs.

A portion of the net proceeds were used to repay $31 million of borrowings previously outstanding under the Company’s revolving credit facility with Squadron.

On September 20, 2022, the Company issued an aggregate of 1,525,000 shares of common stock to Squadron upon exercise of the pre-funded warrants.

These partnerships allow for exclusive distribution in children's hospitals across the United States and serve as supporting avenues for us to focus on high-volume children's hospitals.

On August 05, 2024, the Company replaced an $80 million credit agreement with MidCap Financial with a $100 million term loan and private placement arrangement with Braidwell LP which includes a $50 million term loan and $50 million of convertible notes.

The term loan consists of an initial term loan of $25 million and access to a delayed draw term loan facility for an additional $25 million, subject to certain terms and conditions.

The term loan consists of an initial term loan of $25 million and a delayed draw term loan facility of an additional $25 million, withdrawn in June 2025.

Our largest investor is Squadron, a private investment firm based in Granby, Connecticut.

9 unchanged sentences

• We are committed to fostering an environment that is respectful, compassionate, and inclusive of everyone in our community, which is communicated in our diversity and inclusion policy.

For eight years we have been recognized by the Indiana Chamber of Commerce - Best Companies to Work in Indiana.

• The Company and its Board of Directors understand the value of diversity.

In 2022 and again in 2023, the Company added diverse Directors to our Board and will continue its Board diversity initiative in the future.

For nine years we have been recognized by the Indiana Chamber of Commerce - Best Companies to Work in Indiana.

We believe effectively managing our priorities, as well as increasing our transparency related to social impact programs, will help create long-term value for our stakeholders.

3 unchanged sentences

http://www.orthopediatrics.com without charge, as soon as reasonably practicable, after such reports are electronically filed with, or furnished to, the Securities and Exchange Commission.

The SEC maintains an internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including the Company.

The SEC maintains an internet site that contains reports, proxy and information statements, and other information regarding issuers that file

electronically with the SEC, including the Company.

Those filings are accessible on the SEC’s website at http://www.sec.gov .

We are the only global medical device company focused exclusively on providing a comprehensive trauma and deformity correction, scoliosis and sports medicine product offering to the pediatric orthopedic market in order to improve the lives of children with orthopedic conditions.

We are the only global medical device company focused exclusively on providing a comprehensive trauma and deformity correction, scoliosis and sports medicine/other product offering to the pediatric orthopedic market in order to improve the lives of children with orthopedic conditions.

We design, develop and commercialize innovative orthopedic implants, instruments and specialty bracing products as well as provide O&P clinic services to meet specific needs of pediatric surgeons and their patients, who we believe have been largely neglected by the orthopedic industry.

5 unchanged sentences

We address this unmet market need and sell the broadest product offering specifically designed for children with orthopedic conditions.

We currently market over 75 surgical and bracing systems that serve three of the largest categories within the pediatric orthopedic market:

(i) trauma and deformity correction, (ii) scoliosis and (iii) sports medicine procedures.

We currently market 87 surgical and bracing systems that serve three of the largest categories within the pediatric orthopedic market:

(i) trauma and deformity correction, (ii) scoliosis and (iii) sports medicine/other procedures.

Our products have proprietary features designed to:

12 unchanged sentences

As of December 31, 2025, our U.S.

sales organization consisted of multiple direct sales representatives as well as over 40 independent sales agencies employing over 230 focused sales representatives.

sales organization consisted of several direct sales representatives as well as over 30 independent sales agencies employing 232 focused sales representatives.

Increasingly, these sales agencies are making us the anchor line in their businesses or representing us exclusively.

Sales from such sales agencies represent ed 56% and 59% of our global revenue in 2025 and 2024, respectively.

Outside of the United States, our sales organization consisted o f a network of more than 70 independent stocking distributors, 14 indepen dent sales agencies and multiple direct sales representatives.

Outside of the United States, our sales organization consisted o f a network of more than 80 independent stocking distributors, over 40 indepen dent sales agencies and several direct sales representatives.

We sell our products in over 75 countries outside of the United States.

We collaborate with pediatric orthopedic surgeons in developing new surgical and bracing systems that improve the quality of care.

We have an efficient product development process that relies upon teams of engineers, commercial personnel and surgeon advisors.

We have an efficient product development process that relies upon teams of engineers,

commercial personnel and surgeon advisors.

We believe our products are characterized by stable pricing, few reimbursement issues and attractive gross margins.

66 unchanged sentences

Trauma and Deformity Correction

Trauma and deformity correction surgical procedures involve placing metal plates and screws on the outside of the bone or long nails inside the canal of the bone, known as flexible and rigid intramedullary nails, to stabilize fractures and allow them to heal.

Trauma and deformity procedures also include osteotomies, or surgical cutting

of the bone, the use of metal implants or external fixation to correct angular bone deformities or limb length discrepancies.

fractures and allow them to heal.

Trauma and deformity procedures also include osteotomies, or surgical cutting of the bone, the use of metal implants or external fixation to correct angular bone deformities or limb length discrepancies.

Trauma and deformity also includes specialized bracing products which are non-surgical in nature.

6 unchanged sentences

The vast majority of these procedures were performed in ambulatory surgery centers.

Sports medicine also includes specialized bracing products which are non-surgical in nature.

Smart Implants

16 unchanged sentences

High-Volume Children's Hospitals Target Market $375 million $260 million $70 million $500 million $80 million $300 million

In the future, we expect to expand our market opportunity by addressing additional categories of the pediatric orthopedic market, such as craniomaxilloacial, upper extremity, pediatric orthopedic oncology, pelvis, and other sports-related injuries along with numerous specialty bracing categories.

In the future, we expect to expand our market opportunity by addressing additional categories of the pediatric orthopedic market, such as craniomaxillofacial, upper extremity, pediatric orthopedic oncology, pelvis, and other sports-related injuries along with numerous specialty bracing categories.

Our Exclusive Focus on Pediatric Orthopedic Surgery and Bracing

24 unchanged sentences

In 2025, we estimate that our products were used to help approxima tely 151,000 chil dren, and over 1,291,000 since inception, when including those served by our acquired companies.

We currently market over 75 surgical and specialized bracing systems, which address pediatric trauma and deformity, scoliosis and sports medicine procedures.

We currently market 87 surgical and specialized bracing systems, which address pediatric trauma and deformity, scoliosis and sports medicine/other procedures.

Our products include features that provide specific advantages for pediatric orthopedic surgeons and their patients, such as surgical instrumentation specifically designed for use in children, proper anatomical sizes and contouring, and proprietary designs that address the unique skeletal anatomy and physiology of a growing child.

11 unchanged sentences

As of December 31, 2025, our U.S.

sales organization consisted of multiple direct sales representatives as well as over 40 independent sales agencies employing over 230 sales representatives.

Outside of the United States, we work with a network of more than 70 independent stocking distributors, 14 independent sales agencies and multiple direct sales representatives.

sales organization consisted of several dire ct sales representatives as well as over 30 independent sales agencies employing over 232 sales representatives.

Outside of the United States, we work with a network of more than 80 independent stocking distributors, over 40 independent sales agencies and several direct sales representatives.

We sell our products in over 75 countries outside of the United States.

We estimate that over 62% of U.S.

We estimate tha t over 62% of U.S.

pediatric trauma and deformity and sco liosis procedures in 2015 were performed in approximately 300 hospitals.

9 unchanged sentences

We believe this culture allows us to attract and retain talented, high performing professionals.

For eight years we have been recognized by the Indiana Chamber of Commerce - Best Companies to Work in Indiana.

For nine years we have been recognized by the Indiana Chamber of Commerce - Best Companies to Work in Indiana.

We believe our focus and commitment to pediatric orthopedics has also enhanced our reputation among pediatric orthopedic surgeons as the only diversified orthopedic company focused on their specialty.

27 unchanged sentences

We have developed a comprehensive portfolio of implants, instruments and specialty bracing solutions specifically designed to treat children with orthopedic conditions within the three categories of the pediatric orthopedic market that we currently serve.

We currently market over 75 surgical and specialized bracing systems that address pediatric trauma and deformity correction, scoliosis and sports medicine/other procedures.

We currently market 87 surgical and specialized bracing systems that address pediatric trauma and deformity correction, scoliosis and sports medicine/other procedures.

Many of our products are available in a variety of sizes and configurations to address a wide range of patient conditions and surgical requirements.

4 unchanged sentences

Global revenue from this category for the years ended December 31, 2024 and 2023 was $145.1 million and $106.8 million or 71% and 72% of total revenue, respectively.

Our scoliosis product category includes our RESPONSE TM systems for treating spinal deformity in children, the BandLoc TM 5.5mm/6.0mm sub-laminar banding system, FIREFLY ® Pedicle Screw Navigation Guides, 7D Flash TM Naviation image guidance system and ApiFix ® Mid-C System as well as providing clinical O&P services.

Our scoliosis product category includes our RESPONSE TM systems for treating spinal deformity in children, the BandLoc TM 5.5mm/6.0mm sub-laminar banding system, FIREFLY ® Pedicle Screw Navigation Guides, 7D Flash TM Navigation image guidance system, VerteGlide TM , ApiFix ® Mid-C System, the Boston 3D scoliosis brace, as well as providing clinical O&P services.

Our global revenue from this category for the year ended December 31, 2025 was $66.0 million, or 28% of total revenue, which represented an increase of 20% over the prior year.

Global revenue from this category for the years ended December 31, 2024 and 2023 was $55.2 million and $37.9 million or 27% and 25% of total revenue, respectively.

In addition to our direct product offering, we invest in complementary enabling technologies that allow us to better serve the children's hospitals in which we sell.

In addition to our core product offering, we offer enabling technologies that complements our core products, which allows us to better serve the children's hospitals in which we sell.

Enabling technologies in our scoliosis space include the FIREFLY ® Technology, a 3D printed and patient-specific Pedicle Screw Navigation Guide as well as the 7D FLASH TM Navigation image guidance system leveraging machine-vision algorithms, including 7D MRVision technology, which allows for radiation-free navigation.

We have exclusive distribution rights to both of these complementary technologies, allowing for exclusive distribution in children's hospitals across the United States.

Sports Medicine/Other

Our sports medicine/other product category primarily includes our ACL, MPFL Reconstruction system and Telos as well as providing clinical O&P services.

Our global revenue from this category for the year ended December 31, 2024 was $4.4 million, or 2% of total revenue, which represented an increase of 11% over the prior year.

Our sports medicine/other product category primarily includes our ACL, MPFL Reconstruction system, MY01 perfusion sensing technology, iotaSOFT cochlear insertion robot, and Telos.

Our global revenue from this category for the year ended December 31, 2025 was $4.0 million, or 2% of total revenue, which represented a decrease of 10% from the prior year.

Global revenue from this category for the years ended December 31, 2024 and 2023 was $4.4 million and $4.0 million or 2% and 3% of total revenue, respectively.

Seasonality of our Products

Our revenue is typically higher in the summer months and holiday periods, driven by higher sales of our trauma and deformity and scoliosis products, which is influenced by the higher incidence of pediatric surgeries during these periods due to recovery time provided by breaks in the school year.

9 unchanged sentences

In 2022, we began development of a new plate and screw platform, called 3P, to modernize and revolutionize trauma and deformity treatment in both the upper and lower extremity.

We anticipate a limited launch of the first system, 3P Hip, in the second quarter of 2025, and of the next system, 3P Small/Mini, toward the end of 2025, followed by launches of additional systems throughout 2026-2028.

These systems will provide surgeons

unparalleled coverage for all plating indications, standardized implants and instruments to improve surgical workflow and inventory efficiency, and novel implants to address currently unmet needs.

We completed a limited launch of the first system, 3P Hip, in the third quarter of 2025, and we expect the next system, 3P Small/Mini, to launch in the first half of 2026, followed by launches of additional systems throughout 2027-2028.

These systems will provide surgeons unparalleled coverage for all plating indications, standardized implants and instruments to improve surgical workflow and inventory efficiency, and novel implants to address currently unmet needs.

Pediatric Nailing Platform | Tibia

We anticipate a continuation of our full-scale launch in 2025 for our recently introduced innovative Pediatric Nailing Platform | Tibia, that will use a similar instrument platform to the Pediatric Nailing Platform | Femur system, which was introduced in 2018.

This new to the market system will treat deformities and traumatic injuries of the tibia.

We continued our full-scale launch in 2025 for our innovative Pediatric Nailing Platform | Tibia, that uses a similar instrument platform to the Pediatric Nailing Platform | Femur system, which was introduced in 2018.

This new to the market system is designed to treat deformities and traumatic injuries of the tibia.

Pediatric Nailing Platform | Retrograde Femur

2 unchanged sentences

GIRO™ Growth Modulation System

The GIRO™ is a tether device that will be fully launched in 2025, intended for guided growth and deformity correction.

The GIRO™ is a tether device that was fully launched in 2025, intended for guided growth and deformity correction.

Supplementing our flagship PediPlate system, this device offers multi-directional flexibility utilizing a cable assembly designed to improve bone contouring and aiding in minimally invasive treatment, with consideration of a future indication for guided rotational correction.

2 unchanged sentences

Our Active Growing Implants will utilize a power source of significantly greater strength and control than current magnetic technology and will be adjustable at the time of implantation and non-invasively over the course of treatment to accommodate the changing clinical needs of patients as they heal, grow and age.

We made significant development progress on this in 2024 including receiving Breakthrough Device designation from the FDA.

This new technology will be available to address severe pathology associated with early onset scoliosis in the near future.

We made significant development progress on this in 2024 and 2025 including receiving Breakthrough Device designation from the FDA.

This new technology will be available to address severe pathology associated with early onset scoliosis in the near future, and will be explored for limb lengthening applications.

Growth Guidance for Scoliosis - VerteGlide™

1 unchanged sentence

This procedure uses rods and pedicle screws attached to specific points in the spine and configured similar to a “track and trolley” system which allows the spine to grow naturally while correcting a spinal curve.

We completed development and we are now working with the FDA on regulatory clearance.

We expect a beta launch of this system in 2025 and a full-scale launch in 2026.

In 2025, we received regulatory clearance from the FDA and in the third quarter had a beta launch of this system.

We expect a full-scale launch in 2026.

Next Generation Scoliosis Fusion System

We are in final development of our next generation scoliosis fusion system, which will include the ultimate surgical experience for pediatric spinal fusion.

We are in final development of our next generation scoliosis fusion system, which will provide the ultimate surgical experience for pediatric spinal fusion.

The system is designed exclusively for pediatric patients and their surgeons, including innovative implant and instrument designs with an advanced digital platform to optimize the procedure.

We expect to launch this system in the first half of 2026.

We expect to launch this system in the fourth quarter of 2026.

OP Specialty Bracing

Our OP Specialty Bracing (OPSB) division continues to advance a robust future product pipeline designed to expand our presence across key pediatric bracing categories.

Building on our rapidly growing portfolio,

forthcoming innovations include solutions such as the Halo Gravity Traction devices, Advanced Sensors, Bilateral Modular Braces, Pavlik Harness, Contracture Management Braces, and pragmatic aids for the hand and arm, each targeting critical needs in deformity correction, fracture management, and postoperative care.

These products complement ongoing development efforts across seven core clinical segments—hip, mobility, cranial, upper extremity, lower limb, prosthetics, and spine—positioning OPSB to deliver a steadily expanding offering with provider and family centric resources designed to support nonoperative pediatric care globally.

Development of Surgical Workflow Optimization Software

We have a number of initiatives underway involving the development of pre-operative planning and intraoperative workflow software to assist surgeons in the treatment of spinal, trauma, and deformity correction conditions as well as the utilization of the Company's product solutions for these conditions.

We have a number of initiatives underway involving the development of pre-operative planning, which leverages machine learning and artificial intelligence, and intraoperative workflow software to assist surgeons in the treatment of spinal, trauma, and deformity correction conditions as well as the utilization of the Company's product solutions for these conditions.

These projects encompass both educational and software as a medical device type offerings leveraging our new Playbook product offering.

1 unchanged sentence

We continue to invest in strengthening our external fixation portfolio, with software improvements launched in 2023 and hardware line extensions in 2024.

In 2025 we will launch a new Titanium HA Pin offering to support both Orthex ® and Drive systems, designed to improve fatigue life and increase flexibility to promote rapid bone healing.

In 2025, we had a limited launch of a new Titanium HA Pin offering to support both Orthex ® and Drive systems, designed to improve fatigue life and increase flexibility to promote rapid bone healing.

Further development will continue to focus on hardware and software upgrades as well as a completely new system for emergency fracture management and to aid in deformity osteotomy stabilization.

9 unchanged sentences

As of December 31, 2025, our U.S.

sales organization consisted of multiple direct sales representatives as well as over 40 independent sales agencies employing over 230 focused sales representatives.

sales organization consisted of several direct sales representatives as well as over 30 independent sales agencies employing over 232 focused sales representatives.

Increasingly, these sales agencies are making us the anchor line in their businesses or representing us exclusively.

Sales to customers from such agencies represen ted 56% of our global revenue in 2025 and 59% in 2024.

Outside of the United States, our sales organization consisted of a network of more than 70 independent stocking distributors, 14 independent sales agencies and multiple direct sales representatives.

Outside of the United States, our sales organization consisted of a network of more than 80 independent stocking distributors, over 40 independent sales agencies and several direct sales representatives.

We sell our products in over 75 countries outsid e of the United States, including the largest markets in the European Union, Latin America and the Middle East, as well as South Africa, Australia and Japan.

2 unchanged sentences

In the near term, we expect to selectively expand the number of international markets we serve, as well as to deepen our penetration of important existing markets such as Brazil and Germany.

In 2024, we opened warehouses in Germany and Australia, and hired a European operations director to continue our growth in the European market.

In 2024, we hired a European operations director to continue our growth in the European market, and we opened warehouses in Germany and Australia.

In 2025, we opened a warehouse in the Netherlands.

In November 2025, we established a legal entity in Brazil to sell and distribute directly to the local market.

We have developed intensive training programs for our global sales organization.

20 unchanged sentences

We are also the founding and leading sponsor of the Pediatric Research in Sports Medicine Society and have significantly increased our sponsorship of the Baltimore Limb Deformity Course.

In addition to these organizations, we support eight pediatric orthopedic fellowships.

In addition to these organizations, we support several pediatric orthopedic fellowships.

Our support of these organizations and fellowships demonstrates our commitment to the clinical training and research they sponsor.

We believe this support enhances our reputation as the category leader in pediatric orthopedics.

Additionally, during 2022, 2023 and 2024, we funded The Foundation for Advancing Pediatric Orthopaedics ("Foundation") as a 501(c)(3) public charity.

Additionally, during 2023, 2024 and 2025, we funded The Armstrong Children's Orthopedic Alliance (ACOA) ("Foundation") as a 501(c)(3) public charity.

The Foundation channels OrthoPediatrics' clinical education funding together with contributions from the general public to support non-commercial education programs and clinical research.

2 unchanged sentences

MD Ortho's specialized clubfoot bracing products are manufactured on-site in our Iowa facility and our Boston O&P facility manufactures numerous braces, including our Boston Brace 3D ® , our DF2 brace and our cranial helmets.

C-Pro Direct Ltd., our recently acquired entity in the UK, also manufactures many of their own products.

Our internal manufacturing, as well as our third-party manufacturers, meet FDA and other country-specific quality standards, supported by our internal specifications and procedures.

2 unchanged sentences

All our manufacturing entities, as well as our device contract manufacturers, are required to be ISO 13485 certified and are registered establishments with the FDA.

Our internal quality management group conducts comprehensive on-site inspection audits of our suppliers to ensure they meet FDA and other country-specific requirements, as necessary.

Our internal quality management group conducts comprehensive on-site inspection audits of our suppliers to ensure they meet FDA and other country-specific

requirements, as necessary.

In addition, we and our suppliers are subject to periodic unannounced inspections by U.S.

14 unchanged sentences

Our issued U.S.

patents expire between 2025 and 2043, subject to payment of required maintenance fees, annuities and other

patents expire between 2026 and 2044, subject to payment of required maintenance fees, annuities and other charges.

As of December 31, 2025, we owned 40 U.S.

31 unchanged sentences

We recognize that building connections between our employees, their families, and the communities we serve creates a fulfilling and positive workplace.

We also partner with over 40 charitable organizations, including medical missions, and other organizations which advance health, wellness and education initiatives for kids - as well as various civic organizations that advance

the communities where we work and live.

Specifically, we have partnered with the World Pediatric Project, to whom we provide surgical products and treatment for children in developing countries, some of whom are flown to the United States for surgery.

14 unchanged sentences

Under the FDCA, medical devices are classified into one of three classes — Class I, Class II or Class III — depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (QSR), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

compliance with the applicable portions of the Quality System Regulation (QSR), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA.

6 unchanged sentences

The purpose of the HDE provision is to encourage the discovery and use of devices intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect not more than 8,000 individuals in the United States per year.

The FDA may grant an HDE, which is an exemption from the effectiveness requirements of sections 514 and 515 of

the FDCA Act, if the FDA determines that the device meets certain criteria.

The FDA may grant an HDE, which is an exemption from the effectiveness requirements of sections 514 and 515 of the FDCA Act, if the FDA determines that the device meets certain criteria.

After HDE approval, the medical device may only be used after Institutional Review Board ("IRB") approval has been obtained.

23 unchanged sentences

• the federal False Claims Act (and similar state laws) prohibiting, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing, or knowingly and improperly avoiding or decreasing, an obligation to pay or transmit money to the federal government.

The government may assert that claim includes items or services resulting from a

violation of the federal Anti-Kickback Statute and constitutes a false or fraudulent claim for purposes of the false claims statute;

The government may assert that claim includes items or services resulting from a violation of the federal Anti-Kickback Statute and constitutes a false or fraudulent claim for purposes of the false claims statute;

• clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices;

37 unchanged sentences

Clinical investigations for medical devices usually require the approval of an ethics review board and approval by or notification to the national regulatory authorities.

Both regulators and ethics committees also require the submission of serious adverse event reports during a study and may request a copy of the final study report.

Both regulators and ethics committees

also require the submission of serious adverse event reports during a study and may request a copy of the final study report.

The Medical Devices Regulation ("MDR") entered into force in May 2017 and, due to the COVID-19 pandemic, was postponed from its original application date of May 2020 to May 2021.

12 unchanged sentences

our devices, which leads to greater costs for collecting such data than under the MDD.

We received our MDR certification on December 10, 2025.

Regulations in the United Kingdom

1 unchanged sentence

New regulations specific to the UK went into effect beginning January 1, 2021 with a transitional period through June 30, 2025.

These regulations may impact our ability to sell our products in the UK.

During the transition period, devices with CE Markings may continue to be sold within the UK.

Devices sold in Northern Ireland will be required to keep the CE Marking after the transition period ends.

In order to comply with the new regulations and continue selling medical devices in the UK following the transition period, the Company must appoint a UK Responsible Person and register the medical devices with the UK's Medicines and Healthcare product Regulatory Agency, or MHRA.

A new conformity assessment must be completed by a UK Approved Body, or UKAB.

The UKAB will audit and examine a product’s technical dossiers and the manufacturers’ quality system.

If satisfied that the relevant product conforms to the relevant essential requirements, the UKAB issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer may then apply the UKCA Mark to the device, which allows the device to be placed on the market throughout the UK.

Once the product has been placed on the market in the UK, the manufacturer must comply with requirements for reporting incidents and field safety corrective actions associated with the medical device.

In order to comply with the regulations and continue selling medical devices in the UK following the transition period, the Company appointed a UK Responsible Person and registered the medical devices with the UK's Medicines and Healthcare product Regulatory Agency, or MHRA.

A conformity assessment was completed by a UK Approved Body, or UKAB.

The UKAB audited and examined each product’s technical dossiers and the manufacturers’ quality system.

Satisfied that the relevant product conforms to the relevant essential requirements, the UKAB issued a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer has applied the UKCA Mark to the device, which allows the device to be placed on the market throughout the UK.

Ongoing, the manufacturer must comply with requirements for reporting incidents and field safety corrective actions associated with the medical device.

Regulation of Medical Devices in Other Foreign Countries

28 unchanged sentences

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 federal Anti-Kickback Statute.

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances.

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its

facts and circumstances.

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 covered business, the federal Anti-Kickback Statute has been violated.

7 unchanged sentences

A claim includes “any request or demand” for money or property presented to the U.S.

The federal civil False Claims Act also applies to false submissions that

cause the government to be paid less than the amount to which it is entitled, such as a rebate.

The federal civil False Claims Act also applies to false submissions that cause the government to be paid less than the amount to which it is entitled, such as a rebate.

Intent to deceive is not required to establish liability under the civil federal civil False Claims Act.

11 unchanged sentences

For example, the advertising and promotion of our products is subject to EU Directives concerning misleading and comparative advertising and unfair commercial practices, as well as other EEA Member State legislation governing the advertising and promotion of medical devices.

These laws 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.

These laws 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.

Also, many U.S.

28 unchanged sentences

On March 12, 2014, the European Parliament formally passed a revised proposal of the Regulation, and the Council of the European Union published its general approach on June 15, 2015.

Trilogue discussion between the European Commission, European Parliament and Council of the European Union have concluded and the GDPR came into force May 25, 2018.

Trilogue discussion between the European

Commission, European Parliament and Council of the European Union have concluded and the GDPR came into force May 25, 2018.

The Regulation implements significant changes to the EU data protection regime.

31 unchanged sentences

In some countries, government reimbursement is the predominant program available to patients and hospitals.

Our commercial success depends in part on the extent to which governmental authorities, private

health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for the procedures during which our products are used.

Our commercial success depends in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for the procedures during which our products are used.

Failure by physicians, hospitals, ambulatory surgery centers and other users of our products to obtain sufficient coverage and reimbursement from third-party payors for procedures in which our products are used, or adverse changes in government and private third-party payors’ coverage and reimbursement policies.

15 unchanged sentences

A key component in ensuring whether the appropriate payment amount is received for physician and other services, including those procedures using our products, is the existence of a Current Procedural Terminology, or CPT, code, to describe the procedure in which the product is used.

To receive payment, healthcare practitioners must submit claims to insurers using these codes for payment for medical services.

To receive payment, healthcare

practitioners must submit claims to insurers using these codes for payment for medical services.

CPT codes are assigned, maintained and annually updated by the American Medical Association and its CPT Editorial Board.

15 unchanged sentences

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.

What changed 10-K

Item 1. Business