Tigon Medical All-Suture Anchors (ASA)

The Tigon Medical All-Suture Anchors (ASA) are soft-tissue fixation devices used to reattach soft tissue to bone in orthopedic procedures. They are provided sterile and preloaded on reusable stainless steel inserters, with indications spanning multiple anatomical sites including the shoulder, elbow, hip, knee, foot/ankle, hand/wrist, and hip for procedures such as rotator cuff repair, ligament reconstruction, and tendon repair.

The device consists of suture anchors in different load configurations with one or more working sutures. The anchors are provided preloaded on inserters made from stainless steel that can be reprocessed after use. The product is substantially similar in design and function to predicate all-suture anchor systems already on the market.

Mechanical testing was performed according to ASTM F543 to evaluate the insertion strength and fixation strength of the Tigon Medical All-Suture Anchors compared to the predicate device.

The device is substantially equivalent because it has the same features, intended uses, and indications as the predicate all-suture anchor devices. Mechanical testing data demonstrated that the Tigon ASA anchors perform comparably to the predicate in both insertion strength and fixation strength, establishing that they are as safe and effective as legally marketed predicate devices already in use for soft-tissue-to-bone reattachment procedures.