CoNextions TR Tendon Repair Receives FDA Clearance

By Julie A. Vetalice

CoNextions TR Tendon Repair Receives FDA Clearance

CoNextions was granted FDA 510(k) clearance to market the CoNextions TR® Tendon Repair System. Expected to launch in May 2022, the novel system addresses traumatic tendon lacerations in the hand, wrist and forearm.

Studies have demonstrated that CoNextions TR supports a strong, fast and smooth repair of tendon lacerations. A prospective randomized clinical trial also showed a lower rate of treatment failure and rupture compared to conventional suture repairs.

"We are pleased with the outcome of 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.

Source: CoNextions Inc.

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory