CONMED Argo Knotless® Anchor

The CONMED Argo Knotless® Anchor is a non-absorbable suture anchor made of PEEK material with a threaded design, supplied as a single-use sterile device. It is intended to reattach soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic surgical procedures, either arthroscopic or open, and stabilizes damaged tissue during healing.

The proposed device is a non-self-punching anchor that is MR Safe, whereas the predicate (Argo Knotless™ SP Anchor) is a self-punching anchor that is MR Conditional. The proposed device has a PEEK tip on the anchor and includes additional instrumentation (bone tap, smooth punch, tapered broaching punch, reamer, drill guide). The proposed device supports use with bioresorbable reinforced implants as a specific SKU, which the predicate does not.

ISO 10993-1 and FDA# G95-1 for biocompatibility. The document references well-established testing methods for pyrogen (bacterial endotoxin), shelf-life, and sterilization validation, but does not cite specific consensus standards beyond biocompatibility.

The proposed device shares identical intended use, principles of operation (non-absorbable suture anchors for soft tissue fixation), materials (PEEK, UHMWPE suture, stainless steel components), sterilization method (EO to SAL 10⁻⁶), shelf-life (18 months), and biocompatibility profile as the predicate. Performance testing (insertion, ultimate pull, displacement resistance, cyclic loading) demonstrates equivalent mechanical performance. The differences—non-self-punching design, MR Safe status, PEEK tip, and ability to use with bioresorbable implants—present no new safety or effectiveness issues and are therefore substantially equivalent.