The US Food and Drug Administration has granted 510(k) approval for Oxford Performance Materials’ (OPM) SpineFab vertebral body replacement (VBR) implant system.
SpineFab system is claimed to be the first and only FDA cleared 3D printed load-bearing polymer device for long-term implantation.
OPM CEO and chairman Scott DeFelice said: "Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM.
"This clearance serves as further confirmation of our ability to repeatedly build fully functional 3D-printed parts and mission critical robust structures."
SpineFab device has been developed for use in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma.
The implants of SpineFab VBR System are said to be 3D printed in 48 sizes by OPM Biomedical, an original equipment manufacturer (OEM) of medical devices.
SpineFab implants will be produced through using OsteoFab process that aggregates OPM’s exclusive 3D printing technology with the firm’s OXPEKK powder formulation to print orthopedic and neurological implants.
In February 2013, the company received FDA approval for its OsteoFab Patient-Specific Cranial Device, while in July 2014, it obtained approval for OsteoFab Patient-Specific Facial Device.
Zimmer Biomet exclusively distributes OsteoFab Patient-Specific Cranial and Facial devices.