VySpine Receives FDA Clearance for 3D Printed LumiVy OsteoVy PEKK Lumbar IBF

VySpine, a spine innovation leader using differentiated materials and designs, has received U.S. Food and Drug Administration (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.
 
The LumiVy OsteoVy PEKK Lumbar IBF combines the osseointegration properties of the 3D printed OXPEKK material and the novel OsteoVy lattice structure unique to Vy Spine.
 
“We are thrilled that Vy Spine has reached this important milestone with its second OsteoFab product approval,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s novel 3D printed PEKK technology and Vy Spine’s unique designs & experience within the spine marketplace will drive substantial adoption of this best-in-class solution.”
 
The LumiVy OsteoVy PEKK Lumbar IBF is offered in numerous footprints and heights, ranging from 6mm to 21mm addressing a full range of lumbar interbody approaches including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal.  
 
Also, the LumiVy OsteoVy PEKK Lumbar IBF implants are available in a range of lordosis, and hyperlordosis. The LumiVy Lumbar IBF System also features IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone.
 
“The LumiVy OsteoVy PEKK Lumbar IBF clearance is another product in a long line of Vy Spine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, President of Product Development for Vy Spine. “As we researched OXPEKK and its unique characteristics, we found that this composition accomplishes what PEEK cannot. We are excited about the OXPEKK material and our continued partnership with Oxford Performance Materials.”