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