Argo Knotless GENESYS Anchor

The Argo Knotless® GENESYS™ Anchor is a biocomposite suture anchor system designed to reattach soft tissue (ligaments, tendons, joint capsules) to bone during orthopedic surgery. It features a bioabsorbable threaded anchor with a PEEK-Optima eyelet that can hold up to six sutures or one bioresorbable reinforced implant, and is supplied as a single-use sterile device sterilized by ethylene oxide.

The proposed device is a non-self-punching anchor compared to the predicate's self-punching and non-self-punching variants. Both use identical materials (bioabsorbable anchor, PEEK-Optima eyelet, UHMWPE suture), sterilization (ETO), shelf-life (18 months), and biocompatibility standards. The proposed device includes additional instrumentation (reamer and drill guide) and is specifically designed for use with bioresorbable reinforced implants via specific SKU, whereas the predicate had only a specific SKU designation.

ISO 10993-1 for biocompatibility and FDA guidance document G95-1 are cited as the applicable standards.

The device is substantially equivalent because it shares identical intended use, principle of operation (soft tissue to bone fixation), design classification, materials, sterilization method, shelf-life, and biocompatibility profile with the predicate. The only design difference—being non-self-punching instead of self-punching—does not alter the fundamental mechanism of action, as both require pre-prepared bone holes and perform identical fixation functions. Performance testing including insertion, cyclic and ultimate pull displacement resistance, plus user validation on cadaveric ligament repairs, demonstrates equivalent safety and effectiveness.