Cutting Edge Spine Receives FDA 510(k) Clearance of the EVOL ha-C

Cutting Edge Spine, a developer and commercializer of bio-active technologies for the spine, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial launch of its latest innovation, the EVOL ha-C cervical inter-body system.
 
The EVOL ha-C system is made of PEEK-OPTIMA HA Enhanced material supplied by Invibio Biomaterial Solutions (Invibio). Cutting Edge Spine implants made from the material have demonstrated early onset bone formation and apposition to it’s implants. The EVOL ha-C system leverages Cutting Edge Spine’s acuity relative to developing systems made from the material in order to offer superior inter-body options to Surgeons looking for superior and early onset new bone formation and bony apposition to the implant during the fusion process.
 
“The EVOL ha-C cervical inter-body system demonstrates the strong confidence we have in our ability to deliver improved clinical outcomes,” said Randy Roof, president and co-founder of Cutting Edge Spine. “The EVOL ha-C cervical system is our second HA Enhanced PEEK-OPTIMA system to be [FDA] 510(k) cleared this year; and with an ALIF, DLIF and OLIF system forthcoming in 2018 Cutting Edge Spine, arguably, will be offering the world’s largest bio-active interbody portfolio.”

Cutting Edge Spine is currently in the process of launching the technology nationwide.
 
“The EVOL ha-C system combines Invibio’s leadership in PEEK and Cutting Edge Spine’s second to none clinical experience and engineering expertise in HA enhanced PEEK Interbodies,” said Kyle Kuntz, manager of Research & Development at Cutting Edge Spine. “Our growing and compelling body of work demonstrates improved clinical outcomes with HA enhanced PEEK. We are proud to have the opportunity to make it available to patients and surgeons.”
 
Founded in 2009, Cutting Edge Spine (CES) is a privately owned medical device organization headquartered in Waxhaw, N.C., dedicated to developing and distributing spinal technologies focused upon inter-body fusion. CES is future ready, providing the market with highly differentiated implant systems that meet the clinical and economic demands of today’s marketplace. CES developed the EVOS-ha system, the first HA-enhanced PEEK Lumbar Inter-body system approved in the United States. The company possesses four FDA-cleared proprietary technologies with more anticipated in 2018.