VySpine (Tallahassee, Florida) said today that FDA has granted a 510(k) clearance for its LumiVy lumbar IBF system, designed for use after lumbar discectomy in fusion procedures.
The LumiVy system features lumbar interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-enhanced.
“The LumiVy Lumbar IBF System is our latest innovation in a series of comprehensive interbody systems being developed by VySpine,” CEO Tom McLeer said in a news release. “The LumiVy system addresses all lumbar approaches while offering the broadest range of differentiated materials for optimal bony integration. Using new materials and surgeon input, we are building exceptional quality, flexibility and pricing into all our products.”
The LumiVy Lumbar IBF System comes in numerous footprints and heights. It addresses a full range of lumbar interbody approaches, including anterior, oblique anterior, lateral, oblique posterior, posterior and transforaminal, according to the company.
In addition, the LumiVy implants are available in a wide range of lordosis. The LumiVy Lumbar IBF system also features IBF-S implants, which have self-drilling screws to aid in anchoring into the bone.