Company: OFIX
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026066
Chunk: 99

Company: Orthofix Medical Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 99
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 in the U.S. are subject to the Federal Food, Drug, and Cosmetic Act (the "FDCA") and the Public Health Services Act as implemented and enforced by the FDA. The regulations that cover our products and facilities vary widely from country to country. The amount of time required to obtain approvals or clearances from regulatory authorities also differs from country to country. 

Unless an exemption applies, each medical device we commercially distribute in the U.S. is covered by premarket notification ("510(k)") clearance, letter to file, or approval of a premarket approval application ("PMA"). The FDA classifies medical devices into one of three classes, which generally determine the type of FDA approval required. Devices deemed to pose low risk are placed in Class I, devices deemed to pose moderate risk are placed in Class II, and devices deemed to pose the greatest risks, requiring more regulatory controls to provide a reasonable assurance of safety and effectiveness, or devices deemed not substantially equivalent to a device that previously received 510(k) clearance (as described below), are placed in Class III. Our Spinal Implants and Global Orthopedics products are, for the most part, classified as Class II devices and the instruments used with these products are generally classified as Class I. Our 7D FLASH Navigation System is classified as Class II and certain accessories thereto are classified as Class I. Our Bone Growth Therapies products and the M6-C artificial cervical disc are currently classified as Class III, and have been approved for commercial distribution in the U.S. through the PMA process. However, an FDA panel recommended that bone growth stimulator devices be reclassified by the FDA from Class III to Class II devices with special controls. For additional discussion of this development, see Item 1A of this Annual Report under the heading "Risk Factors." 

The medical devices we develop, manufacture, distribute, and market are subject to rigorous regulation by the FDA and numerous other federal, state, and foreign governmental authorities. The process of obtaining FDA clearance and other regulatory approvals to develop and market a medical device, particularly from the FDA, can be costly and time-consuming, and there can be no assurance such approvals will be granted on a timely basis, if at all. While we believe we have obtained all necessary clearances and approvals for the manufacture and sale of our products and that they are in material compliance with applicable FDA and other material regulatory requirements, there can be no assurance that we will be able to continue such compliance. 

In 2017, the European Union ("E