Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA Cervical VBR

By Julie A. Vetalice

Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement, made from Invibio Biomaterial's PEEK-OPTIMA™ Hydroxyapatite-Enhanced polymer.

The device comes in two footprints and allows for fine adjustments of height and lordosis using spacers and endplates. A hollow center and holes accommodate autograft or allograft, and the device includes anti-migration features.

Hydroxyapatite is fully integrated into the polymer matrix, as opposed to being simply coated. The enhanced biomaterial offers the same clinical advantages of PEEK OPTIMA Natural, including a modulus similar to that of cortical bone.

This is Omnia's second 510(k) clearance for the device, following an earlier indication for use in the thoracolumbar spine.

Omnia Medical Boxcar VBR - ORTHOWORLD

Source: Invibio Biomaterial Solutions


Tags: 510(k) Clearance, Regulatory