Lincotek receives FDA clearance for SportLinc syndesmosis device
Single-use ankle implant opens OEM licensing pathway for trauma and sports medicine markets
Lincotek has obtained 510(k) clearance (K252081) from the US Food and Drug Administration (FDA) for its SportLinc Syndesmosis Device, a sterile, single-use implant developed to stabilize syndesmotic trauma of the ankle.
The device consists of an ultra-high-molecular-weight polyethylene (UHMWPE) suture tensioned between two low-profile titanium alloy buttons, delivered via a preloaded button-suture assembly housed in a sterile inserter instrument.
It can be used as a standalone solution or alongside plate fixation, and the full system includes a drill, drill guide, and tension handles. It is intended for use in both hospital operating rooms and Ambulatory Surgery Centers.
SportLinc is designed primarily for syndesmosis injuries — commonly known as high ankle sprains — which occur when the ligaments connecting the tibia and fibula above the ankle are damaged, typically through forced external rotation of the foot. The implant is intended to support the affected joint throughout recovery and is also indicated for ankle fractures.
Private labeling and OEM pathways
With FDA clearance in place, Lincotek stated the device is now available for private labeling and can function as a predicate device, giving OEM partners a route to advance development of comparable products in the trauma and sports medicine sectors.
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.
“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.”
Troy Walters, Product Development Director at Lincotek, added: “SportLinc was developed with a focus on balancing strength, flexibility, and ease of use — three elements that are essential in modern orthopedic surgery. It reflects the expertise and dedication of the Lincotek product development team in supporting orthopedic OEMs with continuously innovative solutions.”
Lincotek will also pursue CE Mark certification, with the aim of bringing SportLinc to European markets.
