CoNextions Inc announced on Thursday the receipt of US Food and Drug Administration (FDA) 510(k) clearance (K200028) for its Coronet System, a tenodesis product intended for the fixation of tissue to bone and tissue to tissue.
According to CoNextions, the Coronet's 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.
The company will begin marketing the Coronet in the second quarter of 2020 through a network of orthopaedic distributors across the United States.
CoNextions is a privately-held medical device company based in Salt Lake City, Utah.
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