FDA Clears Novel Cervical Intervertebral PEKK Implant

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a novel cervical intervertebral body fusion system based on a new material, OXPEKK.

According to its supplier, VySpine™, LLC, the new system, brand named ClariVy OsteoVy™ PEKK, provides better osseointegration than PEEK (poly-ether-ether-ketone) which has been demonstrated through in vitro and in vivo studies utilizing animal models. PEKK (polyetherketoneketone) also allows manufacturers to create porous shapes which facilitate bone ingrowth while also providing polymer’s signature lack of radiographic interference and biocompatibility, meaning no fibrotic tissue membrane formation.

According to the FDA 510(k) summary document, the ClariVy Osteo Vy™ system is indicated for “intervertebral body fusion of the spine in skeletally mature patients.” The systems are designed for “use with autogenous bone graft to facilitate fusion” and “one device may be used per intervertebral space.”

Additionally, the implants are intended to be used with “legally cleared supplemental spinal fixation cleared for the implanted level,” namely, at one level in the cervical spine, from C3 to Tl, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).”

It is to be used in patients who “have six weeks of non-operative treatment.”

The device is called the ClariVy™ Cervical IBF System. In order to qualify for 510(k) clearance, the device must be substantially equivalent to a predicate device. The ClariVy Cervical IBF System is substantially equivalent to the primary predicate device of the same name in terms of “material, intended use, levels of attachment, size range, and use with supplemental fixation.”

The ClariVy OsteoVy™ PEKK Cervical IBF System is different from the primary predicate device because it utilizes OXPEKK material. VySpine submitted the device for 510(k) clearance. According to the company, “PEKK (unlike 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.”

VySpine President of Product Development Bret Berry stated, “The ClariVy OsteoVy PEKK clearance is the first in a long line of VySpine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs.”

Berry continued, “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.”

Specifically, PEKK provides higher push-out strength compared to standard PEEK and, as noted earlier, bone growth characteristics comparable to Ti-coated PEEK with significant improvements in implant integrity and radiographic properties.