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Medical Devices / Submissions and Approvals

Omnia Medical VBR Receives 510(k) Clearance for Vertebral Body Replacement System

Dec. 18, 2017
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Omnia Medical VBR received FDA 510(k) clearance for a vertebral body replacement (VBR) system.

The device was manufactured from PEEK-OPTIMA HA Enhanced polymer by Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body.

In PEEK-OPTIMA HA Enhanced, Hydroxyapatite (HA), an osteoconductive material that enhances bone apposition, is integrated into the polymer matrix.

Invibio’s enhanced biomaterial offers clinical advantages such as a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment.

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