Xēnix’s SOLACE SI Fixation with NANOACTIV Gains FDA Nod

Xēnix Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its SOLACE sacroiliac (SI) fixation system with its NANOACTIV surface tech and compatibility with Medtronic’s StealthStation navigation.
 
SOLACE is comprised of 3D printed, threaded implants ranging from 10.5mm or 12mm in length and 30-115mm in length. The implants feature the company’s NANOACTIV nanotech surface as well as helical autograft harvesting flutes and porous channels for bony ingrowth, running the length of the device.
 
The SI fixation system is intended for SI fusion for SI joint dysfunction, including degenerative sacroiliitis and SI joint disruptions; augmenting, immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion; and for fracture fixation of acute, non-acute, and non-traumatic fractures involving the SI joint.
 
The NANOACTIV micro and nano-roughened surface is engineered to improve fixation to adjacent bone and has been designed with nano-scale surface features at a nanometer level. Also, using Medtronic’s StealthStation  and NavLock trackers can help surgeons precisely locating anatomical structures in either open or minimally invasive procedures, according to Xēnix.
 
“The SOLACE Sacroiliac Fixation System is a major first step in the evolution of Xenix Medical beyond an interbody company,” Xēnix president Ryan Phillips told the press. “Leveraging our expertise in additive manufacturing, this system opens the door to a new level of opportunity for the company to grow within our current and future distribution channels. The SOLACE system is the only nanotechnology sacroiliac fixation system on the market designed specifically for a lateral, oblique or posterior sacral alar iliac technique, giving surgeons complete versatility with a best-in-class technology platform. This system will also provide independent distributors a superior option to compete with the industry leader in this space, which predominantly utilizes a direct sales force.”