Xēnix Gets FDA OK for NANOACTIV Nanotech Surface

Xēnix Medical, a surgical implant company focused on spinal fusion surgery, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for nanotechnology designation of its neoWave interbody fusion implants, which feature the company’s NANOACTIV surface technology.
 
NANOACTIV micro and nano-roughened surfaces aim to improve fixation to adjacent bone and were designed with nano-scale surface features at the nanometer level. The company said these features have shown the ability to elicit endogenous cellular and biochemical response, represented by differentiation of mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix in-vitro, compared to an untreated surface.
 
“My clinical results using these implants lead me to believe that the unique fully porous implant, large endplate contact area and nano scale surface are key to helping patients achieve optimal clinical outcomes, while reducing the incidence of subsidence and maintaining favorable imaging characteristics,” Robert Hirschl, MD, founder and neurosurgeon in Orlando, Fla. told the press.
 
neoWave interbody tech touts a 3D-printed lattice design that the company said retains strength and reduces device stiffness without using traditional implant framework or solid walls. The neoWave matrix, according to Xēnix, was demonstrated to increase endplate surface area and resistance to subsidence compared to a similar device with a solid framework and/or traditional anti-migration teeth.
 
Xēnix Medical’s president Ryan Phillips commented, “Receiving nanotechnology clearance for the neoWave interbody systems is an incredible milestone and achievement for Xēnix, elevating the neoWave implant systems into a distinct device category shared only by a few companies in the industry. As we actively develop a complete line of neoWave interbody devices, the NANOACTIV surface will be a dominant enhancement of future implant systems.