Trax EX Anchor

The Trax EX Anchor is a two-component titanium bone fixation device (screw-in and push-in variants) preloaded with ultra-high molecular weight polyethylene sutures. It is intended for suture or tissue fixation in orthopedic procedures across the foot/ankle, knee, hand/wrist, elbow, and shoulder, including rotator cuff repair, ligament reconstruction, and tendon repair.

The Trax EX Anchors have similar technical characteristics to predicate devices, including identical indications for use, function, and comparable size ranges (3.5mm to 5.0mm diameter). Both components are manufactured from 6AL-4V ELI titanium; the screw-in anchor uses threaded engagement while the push-in anchor uses press-fit engagement. Multiple diameter, length, and distal-end configuration variations are offered to provide surgical flexibility.

Performance evaluation was conducted in accordance with ASTM F3690-24 and the FDA guidance document 'Bone Anchors – Premarket Notification (510(k)) Submissions.' Testing included cyclic pullout testing, static pullout testing, insertion/removal torque testing, and torsional yield strength testing.

The Trax EX Anchors are substantially equivalent to the predicate device (Arthrex DX SwiveLock SL with Forked Eyelet, K150648) based on identical indications for use, comparable function, similar technical characteristics, and equivalent performance demonstrated through bench testing. Any differences are considered minor and do not raise safety or effectiveness concerns.