BioBrace® Extra-Articular Ligament Augmentation Kit

The BioBrace® Extra-Articular Ligament Augmentation Kit is a single-use surgical kit designed to reattach and reinforce soft tissue (ligaments, tendons, joint capsules) to bone in extra-articular knee ligament repair procedures. It combines a bioabsorbable suture anchor (Argo Knotless® GENESYS™ Anchor) with a reinforcing implant (BioBrace® Reinforced BioInductive Implant) to stabilize damaged soft tissue during healing.

The proposed device uses an ethylene oxide-sterilized bioabsorbable threaded anchor with a PEEK eyelet, supplied as a kit with a 5×250mm tapered BioBrace implant and instrumentation. Key differences from predicates: the kit configuration includes three implants and four instruments (versus individual devices); it adds temperature and tamper-evident labels to packaging; and it has a 6-month shelf-life (shorter than the 18–24 months for predicate components). Material composition and sterilization method (ETO to SAL 10⁻⁶) are identical to predicates.

ISO 10993-1 (biocompatibility); ethylene oxide sterilization to SAL (Sterility Assurance Level) of 10⁻⁶; LAL Pyrogen Testing. Performance testing included post-transportation functional testing, transportation conditioning, packaging validation, shelf-life and degradation studies.

The proposed device is substantially equivalent because it has the same intended use (soft tissue reattachment and reinforcement in knee ligament repair), the same mechanism of action (absorbable suture anchor with resorbable reinforcement implant), identical technological characteristics (same materials, sterilization, biocompatibility standards), and comparable predicate devices (K244025, K240090 for the anchor; K242187 for the implant). Performance testing demonstrates it functions as intended, and packaging differences are minor (labels only).