Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed, minimally-invasive, intramedullary bunion correction system.
The Little Silver, N.J.-based company said the clearance was its 4th which leveraged additive manufacturing and 6th complete product line, including its 3D printed core products, biologics and custom equipment.
“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,” Dr. Selene Parekh of Duke Orthopaedics and North Carolina Orthopaedic Clinic said in a press release.
In April, Additive Orthopaedics said it won FDA 510(k) clearance for its 3D printed Locking Lattice Plating System. The Locking Lattice system is designed for the stabilization and fusion of fractures, osteotomies and arthrodesis of small bones.