Lincotek has been granted FDA 510(k) clearance for its 3D printing-enabled SpineLinc Anterior Cervical Implant System.
The SpineLinc Anterior Cervical Implant System is manufactured and assembled at Lincotek's Memphis facility and uses the additive-manufactured Lincotek Bonepore 3D Titanium Porous Structure Technology, characterised by the company’s FDA master file.
The product features multiple footprints, device heights and lordosis angles, and contains machined plate and screw components. It is also offered with single-use instruments designed to be compatible with the needs of Ambulatory Surgical
Centers (ASCs).
“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.”
Lincotek's SpineLinc Anterior Cervical Implant System is available to OEMs for private labelling and can also be used as a predicate device by orthopaedic manufacturers to improve the speed of product development for similar devices.
