Lincotek’s Medical Division has secured FDA 510(k) clearance for its SpineLinc anterior cervical implant system, a 3D printed device manufactured in Memphis and now available to orthopedic OEMs.
“This new approval is great news for OEMs, as it reduces time to market,” observed 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.”
Design Features and Market Positioning
SpineLinc extends Lincotek’s established portfolio of orthopedic innovations. The implant incorporates the company’s additively manufactured Lincotek Bonepore 3D titanium porous structure, supported by an FDA master file. It comes in multiple geometric footprints and lordosis options, blends printed components with machined plates and screws, and is supplied with single-use instruments designed for Ambulatory Surgical Centers. All implants are fully sterile packaged at Lincotek’s Memphis site.
SpineLinc anterior cervical implant system. Image via Lincotek.
“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,” said Francesco Bucciotti, Head of Global and Business Development at Lincotek’s Medical Division.
The system is now available for private labeling and can also act as a predicate device, giving orthopedic manufacturers a faster path to market when developing comparable implant systems.
Rising Wave of FDA Clearances for AM Medical Devices
Manufacturing on Demand
SpineLinc joins a growing list of additive-manufactured medical technologies advancing through the U.S. regulatory system. Over the past several months, the FDA has cleared multiple devices that highlight how 3D printing is moving beyond niche use cases and cementing itself across orthopedics, surgical planning, and regenerative medicine.
In December, US-based 3D printer manufacturer 3D Systems received U.S. Food and Drug Administration 510(k) clearance, expanding its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents, eliminating previous restrictions that confined use to adults and reducing reliance on off-label or compassionate pathways.The move enables routine clinical adoption for adolescent orthopedic oncology and deformity cases, including conditions such as osteosarcoma, Ewing sarcoma, and trauma- or congenital-related limb deformities.
3D Systems’ FDA cleared VSP Orthopaedics. Image via 3D Systems.
Similarly, 3D Systems, working with French MedTech firm TISSIUM, received FDA approval for COAPTIUM CONNECT with TISSIUM Light, a fully bioabsorbable, 3D printed medical device designed to repair peripheral nerve damage. The collaboration combines TISSIUM’s proprietary biomorphic polymers with 3D Systems’ bioprinting expertise to create the first sutureless, atraumatic implant that supports nerve recovery without permanent materials. According to the companies, the polymer enables finely detailed, elastic, biodegradable structures not achievable with traditional manufacturing.
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Author: Paloma Duran
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