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Cutting Edge Spine Announces FDA 510(K) Clearance of its EVOL-SI Joint Fusion System; Bringing Novel Super Hydrophilic Nano-technology to the Sacral-iliac Fixation Market


Cutting Edge Spine, 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 info@cuttingedgespine.comfor more information about the EVOL-SI technology and Cutting Edge Spine.

About Cutting Edge Spine

Established in 2009, Cutting Edge Spine is a proven leader in organic development and commercialization of novel bioactive spinal implant systems focused on improving patient care while offering patients, payors, and providers an optimal fiscal value proposition.

Cutting Edge Spine, LLC 
101 Waxhaw Professional Park Drive, Suite A 
Waxhaw, NC 28173 
(704) 243-0892

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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