Anika Gets 510(k) Clearance for Its X-Twist Fixation System

Bedford, Mass.-based Anika Therapeutics has received 510(k) clearance from the FDA for its X-Twist knotless suture anchor system, which is designed to support healing in rotator cuff repairs and other surgical procedures.

The knotless anchors are easier to use and insert than traditional knotted anchors. They have a short loop of suture secured to the rear end and a channel at the tip of the anchor that captures the loop of suture after it has been passed through the soft tissue, which is tensioned when the anchor is inserted into bone.

The X-Twist sutures feature venting to support cellular infiltration through the anchor, as well as the company’s double-helix X-Spline drive technology, which provides extra torque for anchor insertion.

Surgeons can use the sutures for other soft tissue procedures where a knotless anchor is suitable, including in the foot and ankle, the company said. The system also includes optional knotted sutures.

Anika Therapeutics specializes in joint preservation and early intervention orthopedics.