Additive Orthopaedics’ 510(k) for Digital Fusion Implant

Additive Orthopaedics, LLC., an early stage orthopedic device company, has announced the receipt of 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, in the June 1, 2016 news release. “Design teams really need to think outside the box when considering this innovative manufacturing process. And where better to do that then the Global US Extremity Market valued at $1.3 billion and growing at over 10% per year. We are confident that the market will respond well to this, our patient specific products in development, and our other devices currently being reviewed by the FDA.”

According to Dr. Selene Parekh, professor of surgery in the Department of Orthopaedic Surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic, “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.”

Greg Kowalczyk told OTW, “3D printed devices have the ability to be designed specifically and custom for individual patients. The geometries can be very complex to maximize patient benefits with respect to anatomy and bone healing. Our released products, and the ones still in our pipeline, have been designed to optimize these patient benefits.”