SUBCHONDRAL SOLUTIONS, INC.

Subchondral Solutions, Inc. specializes in two primary device categories: non-bioabsorbable, sterile orthopaedic bone screws and single-use surgical implant trial-implant/sizer holders. Their flagship product, the S-Core™, is a fixation device used in orthopaedic surgeries, while the trial-implant/sizer holders assist surgeons in planning or testing implant fit during procedures.

Subchondral Solutions, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class I or Class II devices, they must comply with FDA regulations, including premarket submissions like 510(k) clearances and Unique Device Identifier (UDI) requirements.

Subchondral Solutions, Inc.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents premarket submissions for Class II devices, demonstrating that the company has shown substantial equivalence to a legally marketed predicate device. The UDI registry ensures traceability and transparency of their products in the supply chain, as required by FDA regulations.

Subchondral Solutions, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as whether a 510(k) submission is required for market authorization.