Tendon Protect (50242)

Kerecis Tendon Protect is a surgical mesh device made from solid fish skin (North Atlantic Cod) sheets at least 0.4 mm thick. It is intended to provide a protective covering around newly repaired tendons for management and protection of tendon injuries where there has been no substantial loss of tissue. The device is biocompatible, bioresorbable, and provides initial barrier support while allowing the repaired tendon to slide within surrounding tissue during healing.

Kerecis Tendon Protect is made from fish skin (North Atlantic Cod), whereas the primary predicate Tendon Wrap uses cross-linked bovine collagen and glycosaminoglycan. Both are solid rectangles, terminally sterilized, and have similar size ranges (subject device: 3×5 cm, 6×9 cm; predicate: 5×5 cm, 10×12.5 cm). Both have identical design form, sterilization method, and comparable shelf life (3 years vs. 2 years respectively).

ISO 10993 series biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, implantation effects, genotoxicity, acute and subacute toxicity); ISO 62366-2 usability engineering; ball burst testing, suture retention testing, and tensile strength testing per FDA Guidance for Surgical Mesh; GLP chicken flexor tendon model for animal testing.

The device is substantially equivalent because it has identical indications for use (management and protection of tendon injuries with no substantial loss of tissue) and similar technological characteristics to the predicate despite using fish skin instead of bovine collagen. Animal testing demonstrated the subject device exhibited similar overall performance to the predicate in terms of tendon healing, with comparable biomechanical function and histopathology results. All biocompatibility and physical property testing met acceptance criteria, and the device is identical to an additional predicate (Kerecis Reconstruct K202430), establishing a known-safe material platform.