Cutting Edge Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its EVOL ha-DLIF direct lateral interbody fusion system.
The EVOL ha-DLIF is made of PEEK-Optima HA-enhanced material supplied by Invibio Biomaterial Solutions. Cutting Edge Spine implants made with this material have demonstrated early onset bone formation and apposition to its implants, the company said in its press release.
“Leveraging our expertise with the PEEK-Optima HA Enhanced material as applied to interbody systems development and clinical validation is paving the way for Cutting Edge Spine to offer the largest worldwide bioactive interbody fusion system portfolio,” said Randy Roof, the comapny’s president, CEO and founder. “Maintaining a concentrated focus on the development and commercialisation of novel bioactive interbody fusion solutions is at our core as a company and we believe that is how we can best serve patients and surgeons on a global scale.”
In addition to the EVOL®ha-DLIF, the North Carolina-based company offers numerous other interbody fusion systems made with the PEEK-OPTIMA HA Enhanced material: EVOL ha-C, EVOL ha-ALIF, EVOS ha.