FDA approval for 3D printed titanium implant

Additive Orthopaedics, LLC., an early stage orthopaedic device company, says that it has received FDA 510(k) clearance 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,’ said Greg Kowalczyk, president and founder of Additive Orthopaedics. ‘Design teams really need to think outside the box when considering this innovative manufacturing process.;

‘3D printing has a major role in the future of orthopaedics,’ said Dr Selene Parekh, professor of surgery in the department of orthopaedic surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic. ‘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.’ 

Additive Orthopaedics has closed its initial seed rounds and recently announced the start of its 2nd round of financing.

This story is reprinted from material from Additive Orthopaedicswith editorial changes made by Materials Today. The views expressed in this article do not necessarily represent those of Elsevier.