Vy Spine’s ClariVy OsteoVy PEKK Cervical IBF OK’ed

Vy Spine has gained U.S. Food and Drug Administration (FDA) clearance for its ClariVy OsteoVy PEKK cervical IBF for intervertebral body fusion at one level in the cervical spine, from C3 to T1, to treat degenerative disc disease (DDD).
 
The device combines the osseointegration properties of the OXPEKK material and OsteoVy lattice structure. PEKK implants, according to the company, demonstrate bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, increase in bony apposition over time, and higher push-out strength compared to standard PEEK.
 
“The ClariVy OsteoVy PEKK clearance is the first 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, told the press. “As we researched OXPEKK and its unique characteristics, we began to realize that its 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 to make this new device possible.”
 
“We are thrilled that Vy Spine has reached this important milestone,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s novel, 3D printed OsteoFab technology and Vy Spine’s innovative designs and experience within the spine marketplace will drive substantial adoption of this best-in-class solution.”