Omnia gets FDA 510(k) clearance for vertebral body replacement system
Omnia Medical has received FDA 510(k) clearance for a vertebral body replacement (VBR) system for use in the thoracolumbar spine to replace collapsed, damaged or unstable vertebral body.
The VBR system is manufactured from PEEK-Optima HA enhanced polymer through a collaboration with Jalex Medical on product development and regulatory activities and Invibio Biomaterial Solutions who pioneered medical PEEK. It is the first PEEK-Optima HA enhanced VBR system to enter the U.S. market.
“Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated into the structure of the implant is a real advance for our patients as it potentially offers improved outcomes,” neurosurgeon Robert Gewirtz said. “I am happy that I was able to partner in this collaboration to help bring the product to market.”
The single-use device is available in two footprints. It allows for fine adjustments of height and lordosis using spacers and endplates and has a hollow center and holes to allow for autograft or allograft. It also promotes bone formation and reduces anti-migration features.
“We are happy to be the first to be granted FDA 510(k) clearance for a vertebral body replacement system manufactured from PEEK-Optima HA Enhanced biomaterial,” Steve Anderson, VP of marketing at Omnia Medical, said. “This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure. Working with Jalex Medical and Invibio Biomaterial Solutions was an excellent experience – and will hopefully enable surgeons and patients to benefit from the new solutions.”