FDA OKs CoNextions’ TR Tendon Repair System

Tendon repair firm CoNextions has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its TR tendon repair system to address traumatic hand, wrist, and forearm tendon lacerations.
 
CoNextions expects to launch the system in May.
 
“We are pleased with the outcome of the FDA’s review of our 510(k) submission supported by a ninety patient clinical trial and are excited about the upcoming introduction and commercial launch of the product,” Jeffrey Barnes, president and CEO of CoNextions told the press.
 
Dan Gruppo, exec VP of sales and marketing, added, “Our network of independent sales distributors is well positioned to offer the CoNextions TR device to orthopedic surgeons both in the U.S. and abroad as a better alternative to the current standard of care.”
 
Studies have shown CoNextion TR enables faster and smoother tendon laceration repair. A clinical trial also showed lower treatment failure and rupture rate compared to suture repairs.
 
Founded in 2011, CoNextions is a privately-held company located in Salt Lake City, Utah. They are an innovation-based medical device company whose mission is while putting quality first, improve the lives of patients by revolutionizing soft tissue repair with safe, innovative, and easy to use medical devices. Image courtesy of PRNewsfoto/CoNextions.