Dallen Medical’s Shoulder Fixation Band Gets FDA OK
Bone fixation and compression devicemaker Dallen Medical said Tuesday it has received FDA 510(k) clearance for its Tensyn Band for acromioclavicular joint and coracoacromial ligament repair in shoulder separations. The device uses knotless banding to stabilize soft tissue in the shoulder, enabling natural joint movement not possible with screw fixation, the San Clemente, Calif., says.
The Tensyn Band is also wider than other available bands, allowing fixation pressure to be distributed across a larger surface area and making it easier for surgeons to handle during the procedure. Dallen says other wire-like devices, which are narrower, concentrate pressure and can risk injury to the surgeon’s hands.
This is the third FDA clearance for the Tensyn Band portfolio of products and extends the platform to the upper extremities, says Dallen Medical CEO David Mills. The latest addition is expected to appeal particularly to hospitals and surgery centers that treat patients with sports injuries. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.