Lincotek’s SpineLinc to reduce time to market for orthopedic manufacturers.
Parma, Italy | January 13, 2026: The Medical Division of Lincotek – global solution provider for services in the medical devices industry – has announced that the U.S. Food and Drug Administration (FDA) has granted 510k clearance for the company’s SpineLinc Anterior Cervical Implant System (K250764) — manufactured, assembled, and packaged at its Memphis facility.
The creation of SpineLinc is the latest in a long history of success by the Lincotek’s product development team in the field of medical devices, as the company builds on its reputation as a complete solution provider and strategic partner for orthopedic manufacturers.
With multiple footprints, device heights and lordosis angles, SpineLinc’s body makes use of the additive-manufactured Lincotek Bonepore® 3D Titanium Porous Structure Technology, characterized by the company’s FDA master file. The product also contains machined plate and screw components and is offered with single-use instruments designed to be compatible with the needs of Ambulatory Surgical Centers (ASCs). It is sterile packaged in Lincotek’s facility in Memphis, Tennessee.
“This new approval is great news for OEMs, as it reduces time to market,” observes 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.”
Francesco Bucciotti, Head of Global and Business Development at Lincotek’s Medical Division, added: “The 510k 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.”
The new product is available to OEMs for private labelling and can also be used as a predicate device by orthopedic manufacturers to improve the speed of product development for similar devices.
About Lincotek
Lincotek is a global solution provider for services in niche markets including Industrial Gas Turbines, Aerospace and Medical Device applications, as well as a leading manufacturer of industrial coating equipment and one of the most respected producers in the Additive Manufacturing field. The Group is family-owned and has more than 1,800 employees located in 18 production facilities across Europe, North America and Asia – lincotek.com.
Media Contact: Francesca Pedrotti, Head of Global Communication – Lincotek | marketing@lincotek.com