Additive Orthopaedics, LLC., an orthopaedic device company, announced today that is has received FDA 510(k) clearance for its 3D printed minimally-invasive, intramedullary Bunion Correction System, to address alignment and stabilization of bunions.
Dr. Selene Parekh, Professor of Surgery in the Department of Orthopaedic Surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic, “This new 3D printed implant allows us to have features in plates that we cannot get with standard manufacturing processes. Namely, it allows an area of the plate to provide additional fixation and strength over time enabling bone to grow onto and through the plate. The hope is that a feature like this will allow for more reliable integration and alignment of bones following a bunion procedure.”
This is the Company’s fourth 510(k) clearance leveraging additive manufacturing and 6th complete product line, which includes their 3D printed core products, biologics, and customs for limb salvage and complex revision cases. Surgeons have implanted over 400 of their individual devices since the first full commercial product launch at the end of 2016. The Company has recently closed a Series A Round of $1M.