Additive Orthopaedics Announces the 510(k) Clearance of Their 3D Printed Digital Fusion Implant for the Global Extremities Market

LITTLE SILVER, N.J., June 1, 2016 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed titanium digital fusion implant, to address the over 1.1M US 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 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.”

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

About Additive Orthopaedics, LLC.
Additive Orthopaedics is an early stage orthopaedic company focused on leveraging the patient, technological and cost benefits of additive manufacturing into the global extremities market.

Greg Kowalczyk

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SOURCE Additive Orthopaedics, LLC.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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