CoNextions Inc., an innovator in tendon repair, is pleased to announce that CoNextions TR® Tendon Repair System has received FDA 510(k) Clearance. Expected to launch in May 2022, the novel system addresses traumatic tendon lacerations in the hand, wrist, and forearm.
“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,” said Jeffrey Barnes, President and CEO of CoNextions.
Dan Gruppo, CoNextions Executive Vice President of Sales and Marketing, explained, “Our network of independent sales distributors is well positioned to offer the CoNextions TR device to orthopaedic surgeons both in the US and abroad as a better alternative to the current standard of care.”
Studies have demonstrated the CoNextions TR enables a stronger, faster and smoother repair of tendon lacerations. A prospective randomized clinical trial also showed a lower rate of treatment failure and rupture compared to conventional suture repairs. The CoNextions TR device is another example of CoNextions’ commitment to providing innovative and advanced solutions for soft-tissue repair leading to improved patient outcomes and surgeon experience. CoNextions Medical continues to revolutionize tendon repair®.