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Xēnix Medical received FDA 510(k) clearance to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation Navigation.
SOLACE Sacroiliac Fixation comprises 3D-printed, threaded implants ranging from 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 bony ingrowth running the length of the device.
SOLACE 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.
The NANOACTIV micro and nano-roughened surface is designed to improve fixation to adjacent bone and has been engineered with nano-scale surface features at a nanometer (10-9) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by differentiation of human mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix in vitro, as compared to an untreated surface.
Source: Xēnix Medical
