Picture: Lincotek
The medical technology division of Lincotek has received 510(k) clearance from the U.S. Food and Drug Administration for its SpineLinc Anterior Cervical Implant System. The implant system is manufactured, assembled, and sterile packaged at the company’s Memphis site and is intended for use in cervical spine surgery. The approval highlights the growing role of additive manufacturing in the series production of regulated medical devices.
At the core of the system is a titanium implant body produced using additive manufacturing. Lincotek relies on its Bonepore 3D titanium structure, a porous geometry specifically designed to promote osseointegration. Such open-porous structures can only be realized to a limited extent using conventional manufacturing methods, whereas metal 3D printing allows precise control over porosity, stiffness, and surface characteristics. The additively manufactured implant body is complemented by conventionally machined plate and screw components, reflecting hybrid manufacturing concepts that are increasingly common in medical technology.
The SpineLinc system is available in various heights and lordotic angles to accommodate different anatomical requirements. The instruments are designed as single-use variants and are therefore tailored to workflows in ambulatory surgery centers. For device manufacturers, Lincotek offers the product as a private-label solution, and it can also be used as a reference system for the development of similar implants.
“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 FDA’s decision shows that additively manufactured implants are increasingly being recognized as an established option in orthopedic care, particularly when manufacturing, quality assurance, and regulatory approval are closely integrated.
