Anatomic Implants/AddUp
AddUp is working with medical device firm Anatomic Implants to get FDA 510(k) clearance for a 3D printed toe joint replacement.
Anatomic Implants is believed to be the first company to develop and patent a 1st metatarsophalangeal (MTP) joint that ‘nearly perfectly’ replicates the human anatomy. It has developed this MTP toe joint with metal 3D printing technology.
Working with AddUp, Anatomic Implants has utilised the FormUp 350 metal 3D printing system to qualify the implant for submission to the FDA. With the FormUp 350, Anatomic Implants has produced the MTP toe joint – which has been designed with fine detailed lattice structures – in a titanium material.
The complex lattice geometries have been integrated to facilitate a ‘near perfect’ replication of the MTP toe joint, which is located at the base of the big toe and is one of the three main points used for balance. It is also often the first joint in the foot to develop osteoarthritis. The market for MTP joint reconstruction, however, has been deemed by Anatomic Implants to be underserved. There are very few products, according to Anatomic Implants, with none offering the potential to support bone-in growth as well as the MTP joint.
Anatomic Implants has thus turned to additive manufacturing technology to promote osseointegration through the integration of a porous structure in its 3D printed MTP toe joint replacement product. This capacity for osseointegration will give the implant a much higher chance of bonding to the bone, helping to reduce the likelihood of the implant being rejected by the body.
By submitting a 510(k) to the FDA, a comprehensive review of safety and performance data for the implant will now be carried out to determine if it is ‘substantially equivalent’ to an implant already on the market. Having already completed several tests, Anatomic Implants is expecting to receive FDA 510(k) clearance by Q3 2024.
“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. [Scott W.] Nutter and I sought out to make a more anatomic design by leveraging the latest technologies adopted by the industry & FDA,” commented 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.”
“AddUp is committed to supporting the development of cutting-edge solutions for the medical market,” added 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.”
Armadillo Additive installs AddUp Form 350 additive manufacturing system
Armadillo Additive/AddUp
Texan contract manufacturer Armadillo Additive has launched its new advanced additive manufacturing facility with the installation of AddUp’s Form 350 powder bed fusion metal 3D printer.
The new Armadillo Additive facility specialises Grade 23 Titanium and offers metal 3D printing services for the development of medical devices. Its in-house 3D printing capability is supplemented by laser marking, heat treatment and bead blasting.
Armadillo Additive is said to have selected AddUp’s Form 350 machine because of its capacity to produce high-quality medical implants at volume.
“The FormUp 350 is a dream come true for us,” commented Armadillo Additive Director of Operations Noah Smith. “It’s on the cutting edge from both a software and hardware perspective. The large build volume and quad laser system allow us to get production jobs done faster than the competition, while the roller recoater lets us push the design envelope to the next level.”
