Arthrex FiberTak Suture Anchor

The Arthrex FiberTak Suture Anchor is an all-suture soft-tissue fixation device used to attach tendons and ligaments to bone across multiple joints including the shoulder, elbow, knee, hip, ankle, wrist, and hand. It features a push-in design with preloaded sutures and is deployed by impacting into a pilot hole, then manually tensioned to set the anchor in place.

The subject device is identical to the primary predicate Arthrex FiberTak Suture Anchor in design and materials—comprising a 1.3 mm SutureTape (White/Blue) with polyester sheath and polyester/UHMWPE repair suture. It uses the same push-in mechanism with manual tensioning via suture bulging/bunching within the pilot hole. The only substantive difference is the addition of the Acetabular Labral Reconstruction indication, which is supported by comparison to a reference device already cleared for this use.

Straight Pull testing was conducted using a method based on ASTM F3690. This is the only test standard cited in the submission.

The subject device performs statistically equivalent to both the primary predicate and reference devices in straight pull testing under the intended indications for use. Since the device design is identical to the predicate except for the expanded indication, and the reference device (Smith & Nephew Microraptor Knotless Suture Anchor) already has FDA clearance for Acetabular Labrum Reconstruction with equivalent technology, the new indication does not raise different safety or effectiveness questions. Any minor differences between devices are considered non-material to substantial equivalence.