CoNextions announced that it won FDA 510(k) clearance for its Coronet system for the fixation of tissue to bone and tissue to tissue.
The Coronet system is a tenodesis product designed to improve the soft tissue fixation strength of these types of repairs when compared to conventional suture repairs.
Salt Lake City–based CoNextions developed the Coronet platform with a streamlined delivery system to allow for the simultaneous placement of the implant in the bone and soft tissue while providing a knotless repair, according to a news release.
The company said it plans to begin marketing the system in the U.S. during the second quarter of 2020, with a network of orthopedic distributors doing the marketing across the country.
“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,” CoNextions CEO Jeffrey Barnes said in the release. “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.”