SAN CLEMENTE, Calif.–(BUSINESS WIRE)–
Dallen Medical Inc., an innovator in bone fixation and repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tensyn™ Plug, the first adjustable orthopedic fixation device. The Tensyn Plug improves upon its predecessor, the Tensyn Band, by offering a lower profile, knotless fixation implant.
The Tensyn Plug enables surgeons to easily adjust the implant prior to locking into place in order to achieve optimal reduction of the fracture. The Tensyn Plug can be adjusted by simply loosening the screw cap and sliding the cap back before re-positioning and locking the screw cap. Competitive products require manipulation of multiple suture wires to “lock” into place and are not adjustable.
Designed for orthopedic surgeons and podiatrists, the Tensyn Plug is now cleared for syndesmosis, AC/CC joint stabilization, 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 David Mills, Chief Executive Officer of Dallen Medical. “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.
The company’s patented Compressyn™ and Tensyn technologies offer significant improvement over existing products by delivering superior fixation with dynamic compression in sternal closure, small bone and sports medicine applications.
About Dallen Medical Inc.
Dallen Medical is an early-stage orthopedic company whose patented technology provides superior fixation and compression. The company has nine FDA clearances around its Compressyn™ and Tensyn™ technologies and is targeting underserved markets where it can deliver a higher standard of rigid fixation and compression, where warranted, without compromising speed or ease of use. For more information, visit www.dallenmedical.com.
