Dallen Medical Gains Clearance for Ligament Repair Device

San Clemente, Calif.-based Dallen Medical Inc., which makes bone fixation and repair products, has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tensyn band for acromioclavicular (AC) joint and coracoacromial (CC) ligament repair in shoulder separation. The Tensyn band technology offers proprietary, knotless banding for stabilized fixation of soft tissue in the shoulder, ankle and other anatomy while allowing physiologically natural movement of those joints not available with rigid screw fixation.

The Tensyn Band is wide, distributing fixation pressure across a large surface area. This feature is meant to provide greater ease of use in the surgeon’s hands during the procedure.

“This approval marks our eighth FDA clearance as a company and the third within the Tensyn band family of products,” said CEO David Mills. “This new device expands the Tensyn band platform to the upper extremities, providing more options for hospitals and surgery centers treating patients with sports injuries, and positioning the company for product line extensions already in development.”

Based on clinical feedback, the company plans to offer the Tensyn band for AC/CC joint stabilization in two configurations to allow for a variety of surgical techniques.

The Tensyn band technology has also been cleared by the FDA for syndesmosis (a small joint in the ankle) repair.