Sam Brusco, Associate Editor02.01.22
VySpine has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ClariVy cervical IBF system, which is used in anterior discectomy with fusion (ACDF) procedures.
ClariVy Cervical IBF cervical interbody fusion devices are made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. The former has been the interbody device standard for decades. The latter has embedded hydroxyapatite 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 told the press. “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 implants come in numerous footprints and heights—from 4 to 11mm and with or without locking screws. They’re also available in a range of lordosis. The system features IBF-S implants with self-drilling screws for anchoring directly to the bone.
ClariVy Cervical IBF cervical interbody fusion devices are made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. The former has been the interbody device standard for decades. The latter has embedded hydroxyapatite 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 told the press. “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 implants come in numerous footprints and heights—from 4 to 11mm and with or without locking screws. They’re also available in a range of lordosis. The system features IBF-S implants with self-drilling screws for anchoring directly to the bone.