VySpine Cervical Interbody Fusion Device Clears

FDA has cleared a VySpine 510(k) for the ClariVy Cervical IBF System and its use in anterior cervical discectomy with fusion procedures. It features cervical interbody fusion devices made from either Polyetheretherketone (PEEK) Optima LT1, or PEEK Optima HA-Enhanced. “PEEK Optima LT1 has been the standard for interbody devices for decades, featuring radiolucency and a modulus of elasticity close to that of natural bone,” the company says. “PEEK Optima HA-Enhanced has embedded hydroxyapatite fibers to create better bony apposition to the implant.”

ClariVy is offered in numerous footprints and heights, ranging from 4mm to 11mm and available either with or without locking screws. Additionally, the implants are available in a range of lordosis, and feature IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone, VySpine says.