Anika Receives FDA Clearance for X-Twist Knotless Fixation

By Julie A. Vetalice

Anika Receives FDA Clearance for X-Twist Knotless Fixation

Anika Therapeutics received FDA 510(k) clearance to market the X-Twist™ Knotless Fixation System. X-Twist Knotless Fixation is a platform of suture anchors designed to be mechanically strong, easy to use and support healing for procedures such as rotator cuff repair.

The X-Twist Knotless Fixation System affords surgeons a variety of knotless and knotted soft tissue fixation options in a single anchor platform. The 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 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®.

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 supports a knotless fixation solution for rotator cuff repair in patients with insufficient bone quality.

Anika expects to begin U.S. commercialization of the X-Twist Knotless Fixation System in 2H22.

Kevin Stone, Vice President and General Manager, Sports Medicine, said, “Surgeons can use the X-Twist in rotator cuff repair for both medial and lateral row applications, as well as other soft tissue procedures where a knotless anchor is desired. This clearance adds to the family of innovative new products to address high opportunity spaces, such as the shoulder market, that will drive accelerated growth for Anika Sports Medicine and our overall joint preservation portfolio.”

Source: Anika Therapeutics

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory