FDA 510(K) Clearance of its EVOL-SI Joint Fusion System
The commercialization of the EVOL-SI system addresses the needs of orthopedic surgeons and neurosurgeons seeking superior clinical outcomes following sacral-iliac surgery. Waxhaw, NC August 20, 2019 Cutting Edge Spine (https://cuttingedgespine.com), a leader in the organic development and commercialization of bioactive technologies for the spine, today announced the 510(K) clearance of its novel SI joint fusion system, the EVOL-SI. The EVOL-SI features a unique surface modification that is proven to improve osseointegration through superior hydrophilicity and optimized surface chemistry, as demonstrated in over 20 in vitro and in vivo studies. This combination, with optimized nano-roughness, mediates bioactivity and influences tissue regeneration that yields early bone formation, improving mechanical stability, while promoting faster fusion and stronger fixation. “Once again, Cutting Edge Spine has demonstrated its ability to lead the development and commercialization of bioactive spinal solutions that improve patient care,” said Randy Roof, President, CEO & Founder. “Raising the bar in patient care is our core objective, and the EVOL-SI system fully supports this objective; providing a solution that potentially eliminates unfavorable issues historically associated with devices utilized in lateral SI joint fusion procedures.”Cutting Edge Spine is currently in the process of launching the EVOL-SI technology. The company will be exhibiting at the North American Spine Society Annual Meeting in Chicago, IL September 25-28, Booth #2005. Please visit the booth or contact [email protected] for more information about the
EVOL-SI technology and Cutting Edge Spine.