Oxford Performance Materials (OPM) has received 510(k) clearance from the US Food and Drug Administration for its SpineFab VBR implant system—a 3D-printed load-bearing polymer device for long-term implantation.
“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 OPM. “The introduction of our SpineFab system represents exciting news for the company’s entry into the attractive spinal market.”
OPM’s SpineFab device is a vertebral body replacement intended for use in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumour or trauma. To gain this FDA clearance, OPM’s implant system underwent static and dynamic mechanical testing to assure that it meets load and fatigue requirements as well as regulatory guidelines for its intended use.
“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. “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.”
The SpineFab system will be 3D printed in 48 sizes by OPM Biomedical, an original equipment manufacturer of medical devices. Using only biocompatible polymer and laser light, the OsteoFab laser sintering additive manufacturing process is a clean implant production method. All SpineFab implants will be manufactured by OPM utilising the company’s OsteoFab process, which combines OPM’s 3D printing technology with the company’s proprietary OXPEKK powder formulation to print orthopaedic and neurological implants. The result is “a unique and beneficial set of attributes, including radiolucency, bone-like mechanical properties, and bone ongrowth characteristics,” says a company press release.
OPM is currently in discussions with a number of distributors regarding sales channels for its SpineFab system as well as partnership options for orthopaedic devices in development.