3D printer manufacturer AddUp and Anatomic Implants announced that they will jointly submit a 510(k) clearance for the world’s first 3D-printed toe joint replacement.
The implant, designed to replace the first metatarsophalangeal (MTP) joint, utilizes the advanced capabilities of titanium 3D printing to nearly perfectly replicate human anatomy. This joint, located at the base of the big toe, plays a crucial role in the body’s balance and is often affected by osteoarthritis.
AddUp’s FormUp 350 powder bed fusion (PBF) machine was chosen to qualify the implant for FDA submission. This machine is characterized by its ability to produce complex geometries with fine lattice structures that are ideal for implantable medical devices. Since the mid-2000s, the FDA’s Center for Devices and Radiological Health (CDRH), in conjunction with the Center for Drug Evaluation and Research (CDER), has cleared many 3D-printed Class II medical devices through the 510(k) pathway.
“With 1st MTP joint replacement being a largely underserved market, and medical device companies building lattice structures into implantables since the mid 2000’s” explains Anatomic Implants President, David Nutter. “We were excited to partner with AddUp to achieve 510(k) clearance after learning about their proprietary 3D printing technology and seeing how it could benefit the development of the Anatomic Great Toe Joint. We look forward to leveraging the AddUp team and their expertise to validate the world’s first 3D printed toe joint replacement on their FormUp 350.”
The partnership with AddUp aims to obtain 510(k) clearance, a challenge that will be overcome thanks to AddUp’s proprietary 3D printing technology and expertise in validating medical implants.
The 510(k) clearance process requires a comprehensive review of the implant’s safety and performance data to determine if it is substantially equivalent to an implant already on the market. With several tests already completed and 510(k) clearance expected in late Q3 2024, the future looks bright for AddUp, Anatomic Implants and the global market for the first MTP joint replacement.
“AddUp is committed to supporting the development of cutting-edge solutions for the medical market” says AddUp Inc. Deputy CEO, Nick Estock. “Our team at the AddUp Solution Center has the expertise on FDA regulations and qualification protocols to provide a proactive approach to regulatory compliance essential for a successful 510(k) submission. We are excited to be supporting Anatomic Implants through this process to bring the first additively manufactured toe joint replacement to market.”