Mini Superhawk Suture Anchor System

The Mini Superhawk Suture Anchor System is a PEEK-based device designed to fix soft tissue to bone in orthopedic procedures across the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow. The system includes a 3.75mm screw-in anchor with 1.5mm suture tape and a 3.75mm knotless push-in anchor with a suture pull tab, both pre-loaded on inserters and sterilized via ethylene oxide.

The subject device features PEEK anchor construction with knotless suture locking technology, similar to predicate devices. Minor differences include anchor body geometry and dimensions, plus the addition of a smaller diameter screw-in anchor. Both subject and predicate devices are sterile, single-use, pre-loaded on inserters, with identical sterilization methods and shelf life.

Not stated in this summary.

The Mini Superhawk has the same intended use, indications for use, and fundamental scientific technology as the predicate devices (K202153 and K222763). Minor technological differences in anchor geometry and dimensions raise no new safety or efficacy concerns. Bench testing—including insertion torque, insertion force, suture locking force, and cyclic pullout force testing—demonstrated performance equivalent to legally marketed predicates, establishing substantial equivalence.