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Lincotek received FDA 510(k) clearance for its SportLinc Syndesmosis Device, a sterile, single-use implant designed to stabilize syndesmotic trauma of the ankle.
The implant features an ultra-high-molecular-weight polyethylene suture, tensioned between two low-profile titanium alloy buttons. It can be used alongside plate fixation or as a standalone solution, offering flexibility in ankle stabilization. The preloaded button-suture assembly is provided in a sterile inserter instrument, supporting ease of use in the operating room.
The product is available for private labeling and can also serve as a predicate device, enabling OEM partners to accelerate the development and commercialization of similar solutions in the trauma and sports medicine markets.
Francesco Bucciotti, Head of Global Business and Business Development at Lincotek’s Medical Division, said: “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. SportLinci 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.”
Source: Lincotek
