VySpine Announces FDA Clearance for LumiVy Lumbar IBF with NanoVy Ti

Summation

  • VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its LumiVy NanoVy Ti Lumbar IBF System which is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
  • NanoVy Ti is a titanium coating that is mere nanometers thick, adhered to a PEEK LumiVy implant.
  • The LumiVy NanoVy Ti Lumbar IBF System features VySpine’s NanoVy Ti coating technology in partnership with Implant Surfaces.

VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its LumiVy NanoVy Ti Lumbar IBF System which is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

The LumiVy NanoVy Ti Lumbar IBF System features VySpine’s NanoVy Ti coating technology in partnership with Implant Surfaces. NanoVy Ti is a titanium coating that is mere nanometers thick, adhered to a PEEK LumiVy implant. The NanoVy Ti coating is engineered to facilitate direct osteoblast attachment to the entire surface of the LumiVy implant.

The high adhesion and impact resistant NanoVy Ti coating bonds intimately to the PEEK structure, and has been shown to increase expulsion resistance of the LumiVy implant. Furthermore, the NanoVy Ti technology does this without compromising the radiolucency, or favorable modulus of elasticity, of the PEEK material.

The LumiVy NanoVy Ti Lumbar IBF System is a robust, yet elegantly simple system. It is offered in a vast array of footprints for nearly any lumbar interbody approach. Additionally, it is available in a range of sizes, heights, and lordotic angles.

Other FDA News of Interest

Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes

"Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans – particularly children and adolescents – across the country," said Acting Associate Attorney General Benjamin C. Mizer. "This interagency Task Force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this Task Force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority."

Tris Pharma Receives U.S. FDA Approval for Once-Daily ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, the First-and-Only Liquid Non-Stimulant ADHD Medication

ONYDA XR is indicated for the treatment of ADHD as monotherapy or as adjunctive therapy to approved CNS stimulant medications in pediatric patients six years and older. The first non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies and reinforces company's commitment to individuals with ADHD.

Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomer® S360MD Slide Scanner

Indica Labs, an industry leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems, announce that the...

By using this website you agree to accept Medical Device News Magazine Privacy Policy