FDA Clears Lincotek’s SportLinc Syndesmosis Device

Lincotek has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SportLinc Syndesmosis Device, a sterile, single-use implant designed to stabilize syndesmotic ankle trauma.

The implant features an ultra-high-molecular-weight polyethylene (UHMWPE) suture tensioned between two low-profile titanium alloy buttons. It can be used with plate fixation or as a standalone solution, thereby offering flexibility in ankle stabilization. The preloaded button-suture assembly is provided in a sterile inserter instrument to support ease of use in the operating room.

“SportLinc was developed with a focus on balancing strength, flexibility, and ease of use—three elements that are essential in modern orthopedic surgery,” Lincotek Product Development Director Troy Walters stated. “It reflects the expertise and dedication of the Lincotek product development team in supporting orthopedic OEMs with innovative solutions.”

As a single-use system including drill, drill guide and tension handles, SportLinc is designed to meet the needs of both hospitals and ambulatory surgery centers (ASCs), helping streamline procedures and reduce operational complexity.

The device is commonly used in sports trauma and ankle fractures. A syndesmosis injury (a.k.a., a high ankle sprain) damages the ligaments connecting the tibia and fibula above the ankle and is often caused by forced external foot rotation. SportLinc provides support to the injury throughout the healing process.

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.

“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,” said Francesco Bucciotti, head of Global Business and Business Development at Lincotek’s Medical Division. “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.”

Lincotek will work towards a CE Mark to complement the FDA 510(k) approval and bring the product to European markets.

Headquartered in Rubbiano, Parma – Italy, Lincotek is a global solution provider in niche markets including industrial gas turbines, aviation, and medical devices, as well as an industrial coating equipment manufacturer and an additive manufacturing producer. The Group is family-owned and has more than 1,800 employees working in 18 production facilities throughout Europe, North America, and Asia.