Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA VBR

Omnia Medical received FDA 510(k) clearance to market a vertebral body replacement device for use in the thoracolumbar spine. This is reportedly the first PEEK-OPTIMA™ HA VBR to receive FDA clearance.Omnia VBR copyright Jalex Medical

The device, manufactured from PEEK-OPTIMA HA Enhanced polymer, is the product of collaboration among Omnia, JALEX Medical and Invibio Biomaterial Solutions. JALEX provided product development and regulatory support, while Invibio is the provider of PEEK material. The Omnia Medical VBR is available in two footprints and allows adjustments of height and lordosis using spacers and endplates. It features a hollow center and holes to accommodate autograft or allograft while encouraging formation of new bone, and includes anti-migration features.

Early clinical results have demonstrated solid fusion with dense bone apposition at 6 months and improvements in overall pain and neurological function with use of a PEEK-OPTIMA HA Enhanced interbody fusion device. Other fusion devices based on HA Enhanced PEEK-OPTIMA include:

Sources: Omnia Medical; ORTHOWORLD Inc.

Image courtesy of Omnia Medical