Anatomic Implants is working to file an FDA 510(k) submission for the world’s first 3D-printed toe joint replacement.
Anatomic Implants has patented and developed a 1st metatarsophalangeal (MTP) joint replacement that is claimed to nearly perfectly replicate the human anatomy by leveraging titanium 3D printing technology. Through the use of additive manufacturing, a porous structure can be integrated into a design to promote osseointegration, which may give implants a much higher chance of bonding to bone, possibly reducing the occurrence of implant rejection by the body.
To bring their product to market, the company chose AddUp’s FormUp 350 Powder Bed Fusion (PBF) machine to qualify the implant for submission to FDA.
Anatomic Implants has already secured design patents in the U.S., Canada and throughout Europe, which represents the majority of the global 1st MTP joint reconstruction market.
“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.”
Anatomic Implants is working to file an FDA 510(k) submission for the world’s first 3D-printed toe joint replacement.
Anatomic Implants has patented and developed a 1st metatarsophalangeal (MTP) joint replacement that is claimed to nearly perfectly replicate the human anatomy by leveraging titanium 3D printing technology. Through the use of...
Anatomic Implants is working to file an FDA 510(k) submission for the world’s first 3D-printed toe joint replacement.
Anatomic Implants has patented and developed a 1st metatarsophalangeal (MTP) joint replacement that is claimed to nearly perfectly replicate the human anatomy by leveraging titanium 3D printing technology. Through the use of additive manufacturing, a porous structure can be integrated into a design to promote osseointegration, which may give implants a much higher chance of bonding to bone, possibly reducing the occurrence of implant rejection by the body.
To bring their product to market, the company chose AddUp’s FormUp 350 Powder Bed Fusion (PBF) machine to qualify the implant for submission to FDA.
Anatomic Implants has already secured design patents in the U.S., Canada and throughout Europe, which represents the majority of the global 1st MTP joint reconstruction market.
“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.”
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