Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor

The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a fully threaded suture anchor pre-loaded on a disposable inserter with sutures. It is manufactured from either BioComposite (PLLA/β-TCP) or PEEK and is intended for fixation of soft tissue to bone in shoulder rotator cuff repairs. The device is provided sterile, single-use, and packaged in single or 5-pack configurations.

The proposed device differs from the predicate (K173788) through minor modifications to the method of suture fixation to the anchor, creating a closed loop within the anchor body, and by including pre-loaded sutures. The proposed and predicate devices share identical basic design, indications for use, intended use, packaging, shelf-life, biocompatibility profile, manufacturing, and sterilization processes.

Tensile (pull-out) testing was conducted to demonstrate mechanical performance. Bacterial endotoxin testing per EP 2.6.14/USP <85> was performed to verify pyrogen limit specifications. No consensus standards (ISO, IEC, ASTM) are explicitly cited in this summary.

The device is a line extension of the predicate K173788 with substantially identical basic design and intended use for the same anatomical application. Tensile testing demonstrated statistical equivalence in performance to the predicate. The differences—closed-loop suture fixation design and pre-loaded sutures—are characterized as minor modifications that do not raise new questions about safety or effectiveness. Since the indications for use are a subset of the predicate's indications and biocompatibility and manufacturing processes are identical, the differences do not create new risks or alter the fundamental mechanism of action.