VySpine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its LumiVy lumbar IBF system which is designed for use after lumbar discectomy in fusion procedures.
The LumiVy lumbar IBF system features lumbar interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. PEEK Optima LT1 has been the standard for interbody devices for decades due to its radiolucency and a modulus of elasticity close to that of natural bone. PEEK Optima HA-Enhanced has embedded hydroxyapatite fibres to create better bony apposition to the implant, say the company.
Tom McLeer, CEO of VySpine, said: “The LumiVy lumbar IBF system is our latest innovation in a series of comprehensive interbody systems being developed by VySpine.
“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 is offered in numerous footprints and heights, and addresses a full range of lumbar interbody approaches including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal. Additionally, the LumiVy implants are available in a wide range of lordosis. The LumiVy system also features IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone.