US FDA grants 510(k) clearance to Additive Orthopaedics’ 3D-printed fusion implant


The US Food and Drug Administration has granted 510(k) clearance to Additive Orthopaedics for its 3D-printed titanium digital fusion implant.

“Additive manufacturing allows us to develop complex geometries at reasonable manufacturing costs not possible before now with traditional manufacturing,” says Greg Kowalczyk, president and founder of Additive Orthopaedics. 

According to Selene Parekh, professor of Surgery in the Department of Orthopaedic Surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic (both Durham, USA), “3D printing has a major role in the future of orthopaedics.  In today’s cost sensitive health care environment, 3D printing allows us to bring highly complex, lower cost technologies to the market very quickly, with patient specific features that will potentially improve patient outcomes.”