SpineFab VBR approved by FDA

Oxford Performance Materials has been given FDA approval for its 3D printed spinal implant device

The SpineFab VBR implant system is geared toward the thoracolumbar regions of the spine and replaces collapsed, damaged or unstable vertebrae stemming from tumour or trauma.

OPM already has FDA clearance for its cranial and facial devices.

Oxford Performance Materitals CEO, Scott DeFelice, said: "This clearance serves as further confirmation of our ability to repeatedly build fully functional 3-D 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."

To make implants, OPM uses its own 3D printing technology and a proprietary powder formulation, creating devices with bone-like attributes and ongrowth characteristics.

OPM Biomedical president, Severine Zygmont, said: "Our OsteoFab process, combines 3D printing with a unique material chemistry."

"We can now envision devices that will promote bone tissue formation while being imaging friendly and anatomically desirable."

OPM is in discussions with a number of distributors about marketing for its SpineFab VBR system and partnership options for orthopaedic devices under development.