Vy Spine Announces FDA Clearance for VyBrate VBR

Bountiful, UT – January 13, 2025—VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its VyBrate VBR System which is designed for use in both the cervical and thoracolumbar spine for vertebral body replacement surgery. 

The VyBrate VBR is an innovative device combining the osseointegration properties of the OXPEKK material and the novel OsteoVy lattice structure unique to Vy Spine. Additionally, the VyBrate VBR device is the first vertebral body replacement device on the market made using OsteoVy PEKK.

PEKK, unlike PEEK, implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and significantly higher push-out strength compared to standard PEEK.

Vy Spine’s proprietary OsteoVy lattice structure aids in bony integration as well as wicking, PEKK being a hydrophilic material, to provide even greater benefit as an interbody implant.

“The VyBrate VBR clearance is the latest in a long line of Vy Spine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs.” Bret Berry, President of Product Development for Vy Spine notes. “As we continue to research OXPEKK and its unique characteristics, we have demonstrated this composition accomplishes what we as an industry had always hoped PEEK would accomplish, but PEEK fell short. We are very excited about the OXPEKK material and our partnership with Oxford Performance Materials.”