CoNextions Gains FDA Clearance of Coronet Tenodesis Product

By Julie A. Vetalice

CoNextions Gains FDA Clearance of Coronet Tenodesis Product

CoNextions received FDA 510(k) clearance to market the Coronet™ tenodesis system for fixation of tissue to bone and tissue to tissue. The product is designed to improve the soft tissue fixation strength of these repairs vs. use of conventional sutures, and its delivery system allows for simultaneous placement of the implant in the bone and soft tissue with a knotless repair.

Coronet is slated for U.S. launch in 2Q20 through a national network of distributors.

"This 510(k) furthers our mission at CoNextions while putting quality first, improving the lives of patients by revolutionizing soft tissue repair with safe, innovative, and easy to use medical devices," said Jeffrey Barnes, CEO. "It is a clear example of our unwavering commitment to creating the most clinically effective and technologically innovative tendon repair solutions.  We look forward to Coronet being the first of many exciting products to come."

Product Labels: Arthroscopy Equipment

Tags: 510(k) Clearance, Regulatory