Dallen Medical Gains Clearance for Orthopedic Fixation Device

San Clemente, Calif.-based Dallen Medical Inc., which makes bone fixation and repair devices, has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tensyn plug, an adjustable orthopedic fixation device. The plug improves upon its predecessor, the Tensyn band, by offering a lower profile, knotless fixation implant.

The Tensyn plug can be adjusted before it is locked into place, which helps to achieve optimal reduction of a fracture. The plug can be adjusted by loosening the screw cap and sliding the cap back before re-positioning and locking the screw cap.

The device is now cleared for syndesmosis, AC/CC joint stabilization (acromioclavicular-coracoclavicular joints, found in the shoulder blade), mid-foot (Lisfranc), lower foot, and wrist and hand repair. The device incorporates the company’s proprietary Tensyn knotless banding technology for stabilized fixation of soft tissue in the extremities while allowing physiologically natural movement of those joints not available with rigid screw fixation.

Like the company’s Tensyn band, the Tensyn plug uses a wide suture band, which distributes fixation forces more broadly than alternative products. This broader distribution of fixation pressure is easier on the surgeon’s hands and, therefore, easier to “lock” into place. Other wire-like devices are significantly narrower, concentrating pressure on a focused area within the bone and potentially risking injury to a surgeon’s hands.

“We have evolved our Tensyn band technology one step further, providing an implant with virtually unlimited application across small extremities for fixation with or without plating,” said CEO David Mills. “In addition, the company will be making another submission to the FDA shortly for the expanded use of the Tensyn plug in the knee and hip.”

The Tensyn plug clearance represents the fourth FDA clearance within the Tensyn family, and ninth clearance for the company overall.