Anika Therapeutics, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the X-Twist Knotless Fixation System. The X-Twist Knotless Fixation system is a platform of suture anchors designed to be mechanically strong1, easy to use, and support healing for key repairs such as rotator cuff repair. According to SmartTRAK, there were nearly 670,000 rotator cuff procedures performed in 2021, with the majority of these being performed in the ambulatory surgery center.

The X-Twist Knotless Fixation System affords surgeons a variety of knotless and knotted soft tissue fixation options in a single anchor platform. The feature-rich design includes venting, intended to support cellular infiltration through the anchor; a double helix thread that allows fast and easy deployment; the ability to support the surgeon's preferred combination of multiple sliding suture or tape configurations; and the unique X-Spline™ drive technology which provides more torque transfer for easy anchor insertion. In addition to the shoulder, X-Twist has direct applications in a variety of procedures, including in the foot and ankle, and will initially be available in PEEK-Optima.

The X-Twist represents the newest innovation within Anika's Sports Medicine segment focused on the ASC. Combined with Anika's recent hardware augmentation indication for Tactoset®, its proprietary hyaluronic acid-enhanced injectable bone substitute, the X-Twist clearance differentiates Anika among its competition by enabling it to offer a knotless fixation solution for rotator cuff repair in patients with insufficient bone quality. Anika expects to begin commercializing the X-Twist Knotless Fixation System in the second half of 2022 within the United States.