Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

The Tigon Medical Static Javelin All-Suture Anchors are soft-tissue fixation devices designed to reattach soft tissue to bone in orthopedic surgery. They are indicated for use in procedures including rotator cuff repair, ligament reconstruction, tendon repair, and related procedures across the shoulder, elbow, knee, hip, hand/wrist, and foot/ankle.

The devices are 2.3 mm × 16.5 mm double-loaded all-suture anchors made from stainless steel. They feature different load configurations with USP 2 suture cable and/or 1.5 mm suture tape, available in single sliding suture, knotless, or standalone configurations. The anchors can be implanted via self-punching, pre-awling, or drilling, and the inserters are reprocessable stainless steel devices.

Comparative mechanical testing including fatigue testing, displacement after fatigue testing, and axial pullout testing was performed according to ASTM F3690-24.

The Static Javelin All-Suture Anchors are substantially equivalent to predicate devices because they have equivalent intended use and indications, and major technological characteristics including substantially equivalent materials, size range, method of fixation, and mechanical strength. Mechanical test data demonstrated the candidate devices perform as well as or better than the legally marketed predicate devices.