By Michael Motich-Hou
Oxford Performance Materials was the first company to receive FDA approval for a polymer implant for their unique skull implants. While the company’s biocompatible materials have been deemed safe for implantation, their previous implants, including the aforementioned cranial implant and the OsteoFab Patient-Specific Facial Device, were not load-bearing, limiting the use of their technology and materials to a small region of the body. Today, however, all of that has changed, as the company receives FDA clearance for its SpineFab® VBR implant system, now the first and only 3D printed polymer load-bearing device.
The spinal implant is designed to replace throacolumbar spinal vertebrae (T10 through L1) that may have been damaged due to cancer or trauma. In order to ensure that the SpineFab system would meet FDA load and fatigue requirements, the device ran a gauntlet of static and dynamic mechanical tests.
OPM CEO Scott DeFelice, previously interviewed on 3DPI, speaks about the news, “Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM.” He continues, “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.”