FDA clears the first 3D plates for general use in the lower extremity
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 the geometric flexibility, clinical advantages and manufacturing cost benefits of additive manufacturing in the orthopaedic plating market. These plates can be implanted either alone with locking or non-locking screws, or in conjunction with our 3D printed bone segments through the use of a connection screw. This allows the surgeon to mix and match any wedge and plate combination for various deformities, complex revisions, or other limb salvage procedures,” prez Greg Kowalczyk said in a press release.
Additive Orthopedics said the clearance is the 3rd which utilizes additive manufacturing and its 5th product line. Last September, the company won FDA 510(k) clearance for its 3D printed osteotomy wedge system designed to treat bone fractures or osteotomies in the foot and ankle.
Last June, Additive Orthopaedics won FDA 510(k) clearance for its 3D printed titanium digital fusion implant, according to it’s site.