Lincotek has obtained 510(k) clearance (K252081) from the U.S. Food and Drug Administration (FDA) for its SportLinc Syndesmosis Device, a sterile, single-use implant engineered to stabilize syndesmotic trauma of the ankle. The clearance marks a key step for the company’s Medical Division as it positions the product for commercial deployment with orthopedic OEM partners.

“We pride ourselves on helping customers bring products to market in less than one year from the design concept to the 510k approval, keeping them ahead in an increasingly competitive industry. SportLinc has big commercial potential and will have a strong appeal to clinicians dealing with sports injuries. With FDA clearance in place, we’re now ready to provide a market-ready solution to orthopedic OEMs,” said Francesco Bucciotti, Head of Global Business and Business Development at Lincotek’s Medical Division.

Lincotek secures FDA 510(k) clearance for SportLinc.…