510(k) Clearance of 3D-Printed Digital Fusion Implant

Additive Orthopaedics, LLC, an early stage orthopedic device company, has received FDA 510(k) clearance for its 3D-printed titanium digital fusion implant, to address the over 1.1 million U.S. fusion procedures annually.
 
“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. And where better to do that then the global U.S. extremity market valued at $1.3 billion and growing at over 10 percent 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 orthopedics. In today’s cost sensitive healthcare 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 second round of financing.