AddUp, a metal additive manufacturing OEM, and Anatomic Implants, a medical device startup, are working together to submit a 510(k) for the world’s first 3D printed toe joint replacement. The Washington, DC, startup is the first medical device startup company to patent and develop a 1st metatarsophalangeal (MTP) joint replacement that nearly perfectly replicates the human anatomy by leveraging titanium 3D printing technology.
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 1st MTP joint reconstruction being $500M+ annually, according to the companies, the market is 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. Only through the use of additive manufacturing can a porous structure be integrated into the design to promote osseointegration. Osseointegration gives implants a much higher chance of bonding to the bone, which can reduce the chances of the implant being rejected by the body – leading to better patient outcomes after surgery.
To bring their product to market, Anatomic Implants chose AddUp’s FormUp 350 Powder Bed Fusion (PBF) machine to qualify the implant for submission to the FDA. The FormUp 350 stands out in 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) have approved many 3D printed class II medical devices through the 510(k) pathway since the mid-2000s.
“With 1st 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,” said David Nutter, President of Anatomic Implants. “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. With several tests already completed, 510(k) clearance is anticipated in late Q3, 2024.
Anatomic Implants has been working on the Anatomic Great Toe Joint since its inception in late 2016 and has already secured design patents in the US, Canada, and throughout Europe, which represents the majority of the global 1st MTP joint reconstruction market.
AddUp has vast experience in the medical industry with multiple global OEMs relying on the FormUp 350 for serial production of their medical implants. The company’s North American subsidiary, The AddUp Solution Center, is located in Cincinnati, OH, and is ISO13485 certified.
“AddUp is committed to supporting the development of cutting-edge solutions for the medical market,” said Nick Estock, Deputy CEO of AddUp. “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.