Vy Spine Secures FDA Clearance for Innovative 3D Printed LumiVy OsteoVy PEKK Lumbar IBF

Vy Spine, a leader in spine innovation leveraging advanced materials and designs, has achieved U.S. Food and Drug Administration (FDA) clearance for its LumiVy OsteoVy PEKK Lumbar Interbody Fusion (IBF) device. This innovative implant is designed for intervertebral body fusion at one or two contiguous levels in the lumbar spine, specifically from L2 to S1, for patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis.

The LumiVy OsteoVy PEKK Lumbar IBF uniquely combines the osseointegration benefits of the 3D printed OXPEKK material with Vy Spine’s proprietary OsteoVy lattice structure. Available in multiple footprints and heights from 6mm to 21mm, this device addresses a wide range of lumbar interbody approaches, including anterior, oblique anterior, lateral, posterior, and transforaminal. Additionally, the LumiVy system features IBF-S implants with self-drilling screws for enhanced stability directly to the bone.

“The clearance of the LumiVy OsteoVy PEKK Lumbar IBF exemplifies Vy Spine’s commitment to harnessing our proprietary designs,” said Bret Berry, President of Product Development at Vy Spine. “Our research into OXPEKK has revealed its remarkable properties, surpassing traditional PEEK materials.” Scott DeFelice, CEO of Oxford Performance Materials, noted, “This milestone reflects the powerful synergy between OPM’s cutting-edge 3D printing technology and Vy Spine’s expertise in spine solutions, positioning us for significant market adoption.”