OPM’s SpineFab VBR Implant Wins FDA Nod
Oxford Performance Materials has won FDA 510(k) marketing clearance for its SpineFab vertebral body replacement system, the South Windsor, Conn., devicemaker said.
The three-dimensional printed load-bearing device is meant for long-term implantation, indicated for use in the thoracolumbar regions of the spine to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma, the company says.
This is OPM’s third OsteoFab FDA regulatory approval. The devicemaker previously won clearance for its OsteoFab patient-specific cranial system and its OsteoFab patient-specific facial system in 2013 and 2014, respectively.
The company has an exclusive distribution deal for its cranial and facial devices with Zimmer Biomet. — Jason Scott