The ClariVy cervical IBF system, which consists of cervical interbody fusion devices, is suitable for use in anterior cervical discectomy with fusion (ACDF) procedures
VySpine has secured FDA approval for ClariVy cervical IBF system. (Credit: kalhh from Pixabay)
VySpine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ClariVy cervical IBF system.
The company has developed the ClariVy cervical IBF system for use in anterior cervical discectomy with fusion (ACDF) procedures.
The ClariVy cervical IBF system consists of cervical interbody fusion devices produced using either PEEK Optima LT1 or PEEK Optima HA-Enhanced.
Featuring radiolucency and a modulus of elasticity almost similar to that of natural bone, PEEK Optima LT1 is the standard for interbody devices, while PEEK Optima HA-Enhanced has encapsulated Hydroxyapatite fibers to provide better bony apposition to the implant.
VySpine CEO Tom McLeer said: “The ClariVy Cervical IBF System is the first in a series of differentiated interbody systems being developed by 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.”
VySpine is offering the ClariVy cervical IBF system in various footprints and heights ranging from 4mm to 11mm.
The ClariVy cervical IBF system is also available either with or without locking screws, as well as in a range of lordosis.
The system also consists of IBF-S implants, which feature self-drilling screws to anchor the device directly to the bone. The self-locking screws are designed for quick and easy fixation.
Last January, the company secured 510(k) clearance from the FDA for its VySpan posterior cervical thoracic (PCT) system.
VySpine offers a comprehensive line of core spine products and newly developed specialty products to meet the requirements of both health care providers and surgeons.