Saturday, January 28, 2023

ClariVy Cervical IBF System Receives FDA Clearance

ClariVy Cervical IBF System: VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for the its ClariVy Cervical IBF System which is designed for use in anterior cervical discectomy with fusion (ACDF) procedures.

The ClariVy Cervical IBF System features cervical 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, featuring radiolucency and a modulus of elasticity close to that of natural bone. PEEK Optima HA-Enhanced has embedded Hydroxyapatite fibers to create better bony apposition to the implant.

“The ClariVy Cervical IBF System is the first in a series of differentiated interbody systems being developed by VySpine,” said Tom McLeer, CEO of VySpine. “Using new materials and creative surgeon input, we are building exceptional quality, flexibility, and pricing into all our products. This is just the next step in a series of exciting, innovative product launches scheduled for 2022.”

The ClariVy Cervical IBF System is offered in numerous footprints and heights, ranging from 4mm to 11mm and available either with or without locking screws. Additionally, the ClariVy implants are available in a range of lordosis. The ClariVy Cervical IBF System also features IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone. These screws are self-locking to ensure quick and easy fixation.

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