FDA clearance for ClariVy OsteoVy PEKK Cervical IBF

PHOTO COURTESY OF VY SPINE

Vy Spine received U.S. Food and Drug Administration (FDA) clearance for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).

The ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the OXPEKK material and the OsteoVy lattice structure unique to Vy Spine. Polyetherketoneketone (PEKK) unlike polyether ether ketone (PEEK) implants demonstrate 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 ClariVy OsteoVy PEKK clearance is the first in a long line of Vy Spine implants which will use the unique qualities of our proprietary OsteoVy PEKK designs,” says Bret Berry, president of product development for Vy Spine. “As we researched OXPEKK and its unique characteristics, we began to realize its composition accomplishes what we as an industry had always hoped PEEK would accomplish, but PEEK fell short. We’re very excited about the OXPEKK material and our partnership with Oxford Performance Materials to make this new device possible.”