Oxford Performance Material has cleared a major hurdle. The FDA has approved their 3D printed spinal implants for use in patients across the country.
The SpineFab® VBR implant system is now the first and only 3D printed polymer load-bearing device on the market.
OPM’s CEO Scott DeFelice is thrilled that his team’s hardwork has paid off.
“Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM,” he said. “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 this lays the foundation for future generations of load-bearing OsteoFab implants in the orthopedic industry.”
Although OPM is using 3D printing technology to manufacture their spinal implants, the implants will not be custom made using patient data. Instead, they will come in a range of sizes that are ready-made for implantation in patients with damaged throacolumbar spinal vertebrae (T10 through L1), and will be sold through a distributor, much like traditionally manufactured medical products.
Photo Credit: OPM