3D Printed Bone Segments for Foot and Ankle Fixation Receive 510(k) Clearance
Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, today announced that is has received FDA 510(k) clearance for its Patient Specific 3D Printed Bone Segments, to address internal bone fixation in the ankle and foot.
According to Greg Kowalczyk, President of Additive Orthopaedics, “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.”
According to Brian McLaughlin, VP of Engineering and Operations, “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.”
The Company has seen over 1000 devices implanted since their commercial launch in early 2017. The Company has recently closed a Series B Round of $1M.
About Additive Orthopaedics, LLC.
Additive Orthopaedics is an early stage orthopaedic company focused on the integration of advanced manufacturing and biologics for the benefit of a better patient outcome.
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