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 use of 3D printing technology, should have tremendous patient benefits. Solutions like these, as well as custom and patient specific applications of this technology, will continue to have a major impact on how we treat our patients,” Dr. Selene Parekh of Duke Orthopaedics said in prepared remarks.
The clearance is the 2nd the company has received for products which are manufactured using additive manufacturing techniques.
In June, Additive Orthopaedics won FDA 510(k) clearance for its 3D printed titanium digital fusion implant, according to it’s site.