FDA OKs VySpine’s VyBrate Vertebral Body Replacement System

VySpine, a company specializing in differentiated materials and design for spine technology, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its VyBrate VBR system.

VyBrate VBR is designed for use in both the cervical and thoracolumbar spine for vertebral body replacement (VBR) surgery. It combines the osseointegration properties of the company’s OXPEKK material and the OsteoVy lattice structure unique to the company.

VySpine said the device is the first VBR technology on the market made using OsteoVy PEKK, which was developed in collaboration with Oxford Performance Materials. Unlike standard PEEK implants, PEKK implants have shown bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and much higher push-out strength compared to PEEK.

The proprietary OsteoVy lattice structure helps with bony integration as well as wicking, because PEKK is a hydrophilic material.

“This VyBrate VBR clearance is the latest in a long line of approvals for Vy Spine implants which utilize the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, president of product Development at Vy Spine. “As we continue to research OXPEKK and its unique characteristics, we have demonstrated that this unique 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 continued partnership with Oxford Performance Materials.”

In October 2024, the company received FDA clearance for its LumiVy OsteoVy PEKK Lumbar IBF. The device is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.