SOLACE™ Sacroiliac Fixation System, Featuring NANOACTIV™ Nanotechnology, Obtains FDA Clearance
Wednesday, November 01, 2023
Xēnix Medical, a company specializing in surgical implants for spinal fusion surgery, has officially announced that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) to launch its SOLACE™ Sacroiliac Fixation System. This innovative system incorporates exclusive NANOACTIV™ surface technology and is fully compatible with the StealthStation® Navigation system.
The SOLACE Sacroiliac Fixation System includes a range of 3D printed threaded implants with different diameters (10.5mm or 12.0mm) and lengths (ranging from 30mm to 115mm). These implants feature Xēnix Medical's proprietary NANOACTIV nanotechnology surface, which includes helical autograft harvesting flutes and porous channels designed to encourage bone ingrowth along the device's length.
This fixation system is intended for sacroiliac fusion, addressing issues such as degenerative sacroiliitis and sacroiliac joint disruptions. It can also be employed to augment, immobilize, and stabilize the sacroiliac joint in skeletally mature patients undergoing lumbar or thoracolumbar fusion procedures. Moreover, it is cleared for the fixation of both acute and non-acute fractures involving the sacroiliac joint.
The system has gained approval for use with navigation systems, ensuring precise placement of SOLACE implants and instruments. It utilizes the Medtronic® StealthStation® system and NavLock® trackers for this purpose.
The NANOACTIV surface technology has been developed to enhance fixation to adjacent bone by incorporating micro and nano-roughened surfaces. These surfaces contain nano-scale features at the nanometer level, which have shown the capability to stimulate a cellular and biochemical response, including the differentiation of human mesenchymal stem cells into osteogenic lineage and the production of a mineralized matrix in vitro.