The Medical Division of Lincotek has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpineLinc anterior cervical implant system, which is manufactured at the company’s Memphis, Tenn. facility.

SpineLinc’s body leverages the additively manufactured Lincotek Bonepore 3D titanium porous structure technology characterized by its FDA master file. It combines machined plate and screw components and comes with single-use instruments engineered for the needs of Ambulatory Surgical Centers (ASCs).

“This new approval is great news for OEMs, as it reduces time to market,” said Troy Walters, the product development director of Lincotek’s Medical Division. “SpineLinc demonstrates our understanding of customers’ need for market-ready solutions and the critical importance of acting quickly. By aligning our expertise with their priorities, we can transform ideas into commercial success faster and more efficiently.”

The company said the creation of SpineLinc is the latest in its long history of success by the company’s product development team in the field of medical devices. Lincotek aims to build on its reputation as a complete solution provider and strategic partner for orthopedic manufacturers.

The product is available to OEMs for private labeling and can be used as a predicate device by orthopedic manufacturers to improve product development speed for similar devices.

“The 510(k)k approval by the FDA is an important landmark, because SpineLinc has such a great potential having been engineered with OEMs, surgeons and patients in mind,” said Francesco Buccioti, head of global and business development at Lincotek’s Medical Division.

In March 2025, the company announced it secured a new patent for a 3D-printed, customizable screw with an integrated lattice structure. The screw was designed for spine, sacroiliac (SI) joints, avascular necrosis, and other applications.