CoNextions  announced today that it received a 510(k) clearance (K200028) from the U.S. Food and Drug Administration (FDA) for CoronetTM System, a tenodesis product intended for the fixation of tissue to bone and tissue to tissue.

The Coronet’s novel design improves the soft tissue fixation strength of these repairs compared to conventional suture repairs. A streamlined delivery system allows for the simultaneous placement of the implant in the bone and soft tissue and provides a knotless repair.

“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 CoNextions Medical. “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.”

CoNextions Medical will begin marketing the Coronet in the United States in the second quarter of 2020.  The device will be marketed by a network of orthopaedic distributors across the United States.

Founded in 2011, CoNextions Inc. is a privately-held company located in Salt Lake City, Utah. They are an innovation-based medical device company dedicated to achieving safer, stronger, and more durable tendon repairs worldwide marked by faster rehabilitation, fewer complications, and lower long-term costs.

Source: Company Press Release