AddUp, a metallic additive manufacturing OEM, and Anatomic Implants, a medical system startup, are working collectively to submit a 510(ok) for the world’s first 3D printed toe joint substitute. The Washington, DC, startup is the primary medical system startup firm to patent and develop a 1st metatarsophalangeal (MTP) joint substitute that just about completely replicates the human anatomy by leveraging titanium 3D printing know-how.
The MTP toe joint is situated on the base of the massive toe and is without doubt one of the three details used for steadiness. It’s typically the primary joint within the foot to develop osteoarthritis. With the worldwide marketplace for 1st MTP joint reconstruction being $500M+ yearly, in response to the businesses, the market is underserved with only a few merchandise, none of that are anatomic or have the potential to assist bone-in progress in addition to the Anatomic Nice Toe Joint. Solely by means of the usage of additive manufacturing can a porous construction be built-in into the design to advertise osseointegration. Osseointegration offers implants a a lot greater probability of bonding to the bone, which may cut back the possibilities of the implant being rejected by the physique – main to higher affected person outcomes after surgical procedure.
To deliver their product to market, Anatomic Implants selected AddUp’s FormUp 350 Powder Mattress Fusion (PBF) machine to qualify the implant for submission to the FDA. The FormUp 350 stands out in its capacity to supply various advanced geometries with superb detailed lattice constructions – ideally suited for implantable medical units. The FDA’s Heart for Gadgets and Radiological Well being (CDRH) and the Heart for Drug Analysis and Analysis (CDER) have accepted many 3D printed class II medical units by means of the 510(ok) pathway because the mid-2000s.
“With 1st MTP joint substitute being a largely underserved market, and medical system firms constructing lattice constructions into implantables because the mid-2000’s, Dr. Nutter and I sought out to make a extra anatomic design by leveraging the newest applied sciences adopted by the business & FDA,” stated David Nutter, President of Anatomic Implants. “We have been excited to companion with AddUp to attain 510(ok) clearance after studying about their proprietary 3D printing know-how and seeing the way it may gain advantage the event of the Anatomic Nice Toe Joint. We look ahead to leveraging the AddUp group and their experience to validate the world’s first 3D printed toe joint substitute on their FormUp 350.”
The 510(ok) clearance course of entails a complete assessment of security and efficiency information for the implant to find out whether it is considerably equal to an implant that’s already available on the market. With a number of assessments already accomplished, 510(ok) clearance is anticipated in late Q3, 2024.
Anatomic Implants has been engaged on the Anatomic Nice Toe Joint since its inception in late 2016 and has already secured design patents within the US, Canada, and all through Europe, which represents nearly all of the worldwide 1st MTP joint reconstruction market.
AddUp has huge expertise within the medical business with a number of world OEMs counting on the FormUp 350 for serial manufacturing of their medical implants. The corporate’s North American subsidiary, The AddUp Answer Heart, is situated in Cincinnati, OH, and is ISO13485 licensed.
“AddUp is dedicated to supporting the event of cutting-edge options for the medical market,” stated Nick Estock, Deputy CEO of AddUp. “Our group on the AddUp Answer Heart has the experience on FDA laws and qualification protocols to supply a proactive method to regulatory compliance important for a profitable 510(ok) submission. We’re excited to be supporting Anatomic Implants by means of this course of to deliver the primary additively manufactured toe joint substitute to market.”
The Anatomic Nice Toe Joint shall be on show within the AddUp sales space on the American Academy of Orthopaedic Surgeons (AAOS) Annual Convention in San Francisco, California, from February 13 – 15, 2024.
