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.
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 vitro1, as compared to an untreated surface2. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
1In vitro performance may not be representative of clinical performance
2Data on file
About Xēnix Medical
Xēnix Medical is a surgical implant company focused on the development of novel solutions to advance the science of fusion engineering to enhance the treatment of various pathologies for patients requiring spinal fusion surgery. The company, headquartered in Orlando, Florida, is in active development of multiple unique implant technology platforms and markets its line of spinal implant devices in the United States through a network of independent distributors. To learn more, visit xenixmedical.com