Osprey Suture Anchor

The Osprey Suture Anchor is a PEEK-based knotless suture anchor device designed to fix soft tissue to bone through an arthroscopic approach. It is preloaded on a disposable inserter and comes sterile via ethylene oxide sterilization, intended for use in shoulder, foot/ankle, knee, and elbow procedures including tendon repairs, ligament reconstructions, and stabilization procedures.

The Osprey features a knotless PEEK anchor design with similar principles of operation and sterilization as the predicates. Key differences include anchor body design, anchor body dimensions, insertion method, and suture locking method. The device includes two 2.3mm repair suture tapes and is used with manual surgical instruments (guide drill, cannulated drill, suture passer), distinguishing it from the predicate designs while maintaining equivalent technological foundation.

Not stated in this summary.

The device has the same intended use (soft tissue to bone fixation) and fundamental scientific technology (knotless PEEK anchor) as both predicates (Arthrex Swivelock K173845 and Responsive Valor K180951). Although the Osprey differs in anchor body design, dimensions, insertion method, and suture locking approach, each labeled indication is present in one or both predicates. Bench testing (insertion force, cyclic suture locking force, cyclic pullout force) demonstrated performance equivalent to predicates with no new risks, establishing that technological differences do not raise different safety or efficacy questions.