Additive Orthopaedics said yesterday that it won FDA 510(k) clearance for its patient specific 3D-printed locking lattice plates. The newly cleared devices from the Little Silver, N.J.-based company now have indications from the federal watchdog for the alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as those in the foot and […]
Additive Orthopaedics
FDA clears Additive Ortho’s patient specific 3D printed bone segments
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 […]
Additive Ortho wins FDA nod for 3D printed bunion correction system
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 […]
Additive Orthopaedics wins FDA nod for 3D printed Locking Lattice Plating System
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed Locking Lattice Plating System. The Little Silver, N.J.-based company said the Locking Lattice system is designed for the stabilization and fusion of fractures, osteotomies and arthrodesis of small bones. “We are excited to be one of the first companies to leverage […]
FDA clears Additive Orthopaedics’ 3D-printed osteotomy wedge
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed osteotomy wedge system. The newly cleared device from the Little Silver, N.J.-based company is designed to treat bone fractures or osteotomies in the foot and ankle. “The complex geometry and unique lattice structure, which is only possible through the […]