FDA approves first 3D-printed polymer implant for load-bearing applications

Oxford Performance Materials Inc. (South Windsor, CT) has received 510(k) clearance from the FDA for its SpineFab system, a load-bearing polymer device for long-term implantation. Designed to replace a collapsed, damaged or unstable vertebral body caused by tumor or trauma, the vertebral body replacement (VBR) system is the first and only FDA-cleared 3D-printed device of its kind.

"Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM," said Scott DeFelice, Chief Executive Officer and Chairman of Oxford Performance Materials, in a prepared statement. "This clearance serves as further confirmation of our ability to repeatedly build fully functional 3D-printed parts and mission-critical robust structures. The introduction of our SpineFab system represents exciting news for the company's entry into the attractive spinal market, and lays the foundation for future generations of load-bearing OsteoFab implants in the orthopedic industry."

To gain FDA clearance, OPM's VBR implant system underwent extensive static and dynamic mechanical testing to ensure that it meets load and fatigue requirements as well as regulatory guidelines for its intended use. It is OPM's third successful OsteoFab regulatory clearance.

"We have built a strategy with the patient in mind by working together with clinicians to bring innovative device solutions that anticipate improved surgical outcomes," said Severine Zygmont, President of OPM Biomedical. "Today we have achieved our goal to build the first 3D-printed polymer implant that has been cleared for a load-bearing indication. Our OsteoFab process, which combines 3D printing with a unique material chemistry, is causing the industry to rethink how implants are designed and manufactured. We can now envision devices that will promote bone tissue formation while being imaging friendly and anatomically desirable."

OPM's SpineFab VBR System implants will be 3D printed in 48 sizes by OPM Biomedical, an original equipment manufacturer (OEM) of medical devices. Using only biocompatible polymer and laser light, the OsteoFab laser sintering additive manufacturing process is an extremely clean implant production method. All SpineFab implants will be manufactured by OPM utilizing the company's OsteoFab process, which combines OPM's exclusive 3D printing technology with the company's proprietary OXPEKK powder formulation to print orthopedic and neurological implants. The result is a unique and beneficial set of attributes, including radiolucency, bone-like mechanical properties and bone ongrowth characteristics, according to the company.

OPM is currently in discussions with a number of distributors regarding sales channels for its SpineFab VBR system as well as partnership options for orthopedic devices in development. OPM's OsteoFab Patient-Specific Cranial and Facial devices are distributed exclusively by Zimmer Biomet.