Additive Orthopaedics said yesterday it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments.
The 3D-printed segments are designed to address internal bone fixation in the ankle and foot, the Little Silver, N.J.-based company said.
“This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants. In cases of implant revision, limb salvage, and trauma, often there are no clinically available devices to address the patient’s condition. This is where 3D printed patient specific implants are making significant clinical impacts,” president Greg Kowalczyk said in a press release.
“Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics for osteosynthesis. In several patients, our lattice structures have shown close to 90% boney in-growth after 6 months using no biologics. We are excited to now offer these as patient specific solutions,” engineering & ops VP Brian McLaughlin said in a prepared release.
Additive Orthopedics said that it recently closed a Series B round of financing, bringing in $1 million.