Arthrex PushLock Suture Anchors

The Arthrex PushLock Suture Anchors are two-piece push-in devices made of PEEK (polyetheretherketone) that fix soft tissue (sutures) to bone. They come in sizes ranging from 2.0 to 4.5 mm in diameter and are used across multiple joint procedures including rotator cuff repair, Bankart repair, ACL/ligament reconstruction, and tendon repairs in the shoulder, knee, hip, foot/ankle, elbow, and hand/wrist.

The devices are PEEK anchors conforming to ASTM F2026, with threaded bodies and pre-loaded eyelets on disposable inserters. The Self-Punching variant (3.5 mm) is fully threaded and barbed. All are sterile, single-use, and have a 5-year shelf life identical to predicate devices. MRI safety and sterility assurance levels (SAL) are identical to predicate devices.

ASTM F2026 for PEEK material specification. Testing included product functionality (accelerated aging), sterilization validation, biological safety evaluation, temperature studies, and product-induced radiation studies comparing results to predicate and reference devices.

The Arthrex PushLock Suture Anchors share identical basic design features, intended use, materials (PEEK per ASTM F2026), packaging configurations, shelf-life (5 years), and sterility assurance levels with multiple predicate devices. The only difference is the sterilization method (Arthrex X-ray radiation process), which is a minor modification that does not change the intended use, design, or function. Performance data demonstrates equivalent functionality and safety profiles compared to predicates K061863, K063479, K101679, K151092, K221099, and references K093912 and K181513.