Anatomic Implants and AddUp to submit FDA 510(k) for toe joint replacement made via Additive Manufacturing
February 5, 2024
AddUp Inc., headquartered in Cébazat, France, and Anatomic Implants, a medical device startup based in Washington DC, USA, are working together to submit a US Food and Drug Administration (FDA) 510(k) application for what has been referred to as the world’s first additively manufactured titanium toe joint (metatarsophalangeal or MTP) replacement.
The MTP toe joint is located at the base of the big toe and is one of the three main points used for balance. It is often the first joint in the foot to develop osteoarthritis. With the global market for the first MTP joint reconstruction being over $500 million annually, the market is said to be underserved with very few products, none of which are anatomic or have the potential to support bone-in growth as well as the Anatomic Great Toe Joint. The use of Additive Manufacturing allows for a porous structure to be integrated into the design to promote osseointegration, thereby giving the implants a much higher chance of bonding to the bone, reducing the chances of the implant being rejected by the body. This leads to better patient outcomes after surgery.
The company selected AddUp’s FormUp 350 Laser Beam Powder Bed Fusion (PBF-LB) machine to qualify its product for submission to the FDA. The FormUp 350 was selected for its ability to produce varying complex geometries with fine detailed lattice structures, ideal for implantable medical devices. The FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) has approved many additively manufactured class II medical devices through the 510(k) pathway since the mid-2000s.
“With first MTP joint replacement being a largely underserved market, and medical device companies building lattice structures into implantables since the mid 2000’s, Dr Nutter and I sought out to make a more anatomic design by leveraging the latest technologies adopted by the industry & FDA,” stated David Nutter, Anatomic Implants President. “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 510(k) clearance process involves a comprehensive review of safety and performance data for the implant to determine if it is substantially equivalent to an implant that is already on the market. Several tests have already completed and 510(k) clearance anticipated in late Q3 2024. Anatomic Implants has been working on the Anatomic Great Toe Joint since its inception late 2016 and has already secured design patents in the US, Canada, and throughout Europe, which represents the majority of the global 1st MTP reconstruction market.
“AddUp is committed to supporting the development of cutting-edge solutions for the medical market,” shared Nick Estock, Deputy CEO. “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.”
The Anatomic Great Toe Joint will be on display in the AddUp booth at the American Academy of Orthopaedic Surgeons (AAOS) Annual Conference in San Francisco, California, from February 13-15, 2024.
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