Lincotek gains FDA approval for new cervical implant system
SpineLinc utilizes company’s Bonepore 3D titanium porous structure technology
Lincotek’s Medical Division has been granted 510k clearance from the FDA for its pioneering SpineLinc anterior cervical implant system.
The new product has multiple footprints, device heights, and lordosis angles to offer OEMs complete flexibility, and is available for private labeling as well as use as a predicate device to improve product development timelines for similar devices in orthopedic manufacturing.
SpineLinc’s body uses Lincotek’s proprietary additive manufactured Bonepore 3D titanium porous structure technology, which mimics natural bone structure and promotes better integration, healing, and recovery.
The product also contains machined plate and screw components. Lincotek secured a patent last year for its novel 3D printed orthopedic screw, which incorporates an integrated lattice structure designed to enhance bone ingrowth and stability.
“This new approval is great news for OEMs, as it reduces time to market,” stated Troy Walters, 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 great potential having been engineered with OEMs, surgeons and patients in mind.”
SpineLinc’s release marks another progressive step in the company’s ongoing strengthening as a leader and comprehensive solution provider in the global medical device industry.
In addition to its continued product innovation in orthopedic manufacturing, the company has also significantly expanded its production footprint over the last 18 months, nearly doubling the size of its high-tech Trento (Italy) based headquarters.
Lincotek now has one of the largest AM facilities for medical implants in the area, which is complemented by its Memphis, US facility, where SpineLinc will primarily be manufactured, assembled, and packaged.
