Pressrelease: First FDA approval for HAnano Surface® on a spinal implant
The first spinal device utilizing HAnano Surface to improve osseointegration has now been 510(k) approved by the FDA. Through partnership with Promimic, Cutting Edge Spine developed the EVOL SI Sacroiliac Joint Fusion System, which will be commercially launched later this year.
The HAnano Surface has been in clinical use on the dental implant market for several years, showing faster integration between the bone and the implant. Promimic has established US operations, and is now entering the orthopedic market with multiple OEM partners.