First FDA Clearance for Promimic’s HAnano Surface on a Spinal Implant

The first spinal device using Promimic’s HAnano Surface to improve osseointegration has received FDA 510(k) clearance. Through a partnership with Promimic, Cutting Edge Spine developed the EVOL SI Sacroiliac Joint Fusion System; the device will launch later this year.

HAnano Surface has been in clinical use on the dental implant market for several years. Promimic has established U.S. operations, and is now entering the orthopedic market with multiple OEM partners.

HAnano Surface has been shown to accelerate bone growth in over 30 in vivo and in vitro studies. Rapid and strong osseointegration has been demonstrated through biomechanical, histomorphological and biological evaluations, in combination with over 150,000 clinical applications to date.

Unlike traditional coatings, wherein bone anchors to the coating, HAnano Surface does not act as an interface separating bone from the implant. HAnano Surface is particle-based, and avoids risk for cracking or delamination. Further, since the dimensions of the implant are unchanged, there is no need for new drilling procedures or changes in instrument design.

Source: Promimic

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