Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation Navigation.
The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length. Implants feature Xēnix Medical’s NANOACTIV nanotechnology surface and incorporate helical autograft harvesting flutes and porous channels for boney ingrowth running the length of the device.
The SOLACE Sacroiliac Fixation System is intended for sacroiliac fusion for sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac 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 sacroiliac joint.
The system is also cleared for navigation of the SOLACE implants and instrumentation utilizing the Medtronic StealthStation system and NavLock trackers to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.