VySpine Archives - Medical Design Sourcing

FDA clears intervertebral body fusion system from VySpine

The LumiVy NanoVy Ti Lumbar IBF System. [Image from VySpine’s website]VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral body fusion (IBF) system.

Tallahassee, Florida-based VySpine designed the system for IBF at either one level or two contiguous levels in the lumbar spine. It goes between L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

VySpine designed the system with its NanoVy Ti coating technology, developed in partnership with Implant Surfaces. The nanometers-thick titanium coating adheres to a PEEK LumiVy implant. It facilitates direct osteoblast attachment to the entire surface of the implant.

The company said the high-adhesion, impact-resistant coating bonds intimately to the PEEK structure. It also demonstrated the ability to increase expulsion resistance for the LumiVy implant. VySpine said it does so without compromising the radiol…

FDA clears VySpine’s VyPlate anterior cervical plate system

VyPlate stabilizes the anterior cervical spine from C2 to C7. [Image courtesy of VySpine]VySpine this week announced it received FDA 510(k) clearance for its VyPlate anterior cervical plate system.

Tallahassee, Florida-based VySpine designed VyPlate to stabilize the anterior cervical spine from C2 to C7 by using unicortical screw fixation at the anterior face the vertebral bodies.

The system has plates and screws that are manufactured from titanium alloy as specified by ASTM F-136. The locking mechanism ensures that the bone screws are fully captured within the system.

“The VyPlate ACP System is a unique, elegantly simple system,” CEO Tom McLeer said in a news release. “It offers a great deal of versatility and flexibility while providing ease of use for the surgeon. The VyPlate is intuitive while also being robust and adaptable.”

VyPlate comes in numerous sizes, ranging from a single level to five-level plates. The boy screws can be variable with a …

FDA clears VySpine’s LumiVy lumbar IBF system

VySpine (Tallahassee, Florida) said today that FDA has granted a 510(k) clearance for its LumiVy lumbar IBF system, designed for use after lumbar discectomy in fusion procedures.

The LumiVy system features lumbar interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-enhanced.

“The LumiVy Lumbar IBF System is our latest innovation in a series of comprehensive interbody systems being developed by VySpine,” CEO Tom McLeer said in a news release. “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 comes in numerous footprints and heights. It addresses a full range of lumbar interbody approaches, including anterior, oblique anterior, lateral, oblique posterior, posterior and transforaminal, accordi…

FDA clears VySpine’s interbody fusion system

[Image from VySpine]VySpine announced today that it received FDA 510(k) clearance for its ClariVy cervical interbody fusion (IBF) system.

Tallahassee, Florida-based VySpine designed its ClariVy cervical IBF system for use in anterior cervical discectomy with fusion (ACDF) procedures.

According to a news release, the ClariVy system includes cervical interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. The former has been the standard for interbody devices for decades with radiolucency and a modulus of elasticity close to that of natural bone, while the latter has embedded hydroxyapatite fibers to create a better bony apposition to the implant, the company said.

VySpine offers the ClariVy system in a range of 4mm to 11mm and either with or without locking screws. They are also 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.