Xēnix Medical, a company specializing in surgical implants for spinal fusion surgery, has received FDA clearance for its innovative SOLACE™ Sacroiliac Fixation System. This system features the NANOACTIV™ surface technology and is compatible with the StealthStation® Navigation system.
The SOLACE Sacroiliac Fixation System consists of 3D printed threaded implants with diameters of 10.5mm or 12.0mm and lengths ranging from 30mm to 115mm. These implants are designed with Xēnix Medical's NANOACTIV nanotechnology surface, which includes helical autograft harvesting flutes and porous channels to promote bone ingrowth along the device.
This advanced system serves various purposes, including sacroiliac fusion for patients with conditions like degenerative sacroiliitis and sacroiliac joint disruptions. It also assists in augmenting, immobilizing, and stabilizing the sacroiliac joint in patients undergoing sacropelvic fixation as part of lumbar or thoracolumbar fusion. Moreover, it is cleared for fracture fixation, covering both acute and non-acute fractures involving the sacroiliac joint.
One of the unique features of the SOLACE system is its compatibility with the Medtronic® StealthStation® system, along with NavLock® trackers. This technology helps surgeons accurately locate anatomical structures during open or minimally invasive procedures. The NANOACTIV surface, with its micro and nano-roughened design, enhances fixation to adjacent bone. It has demonstrated the ability to stimulate a cellular and biochemical response, differentiating human mesenchymal stem cells into the osteogenic lineage and promoting the production of a mineralized matrix in vitro, setting it apart from untreated surfaces.
The NANOACTIV implant surface aligns with the criteria outlined in the FDA's nanotechnology guidance document. Notably, it is the only nanotechnology sacroiliac fixation system specifically designed for lateral, oblique, or posterior sacral alar iliac techniques, providing surgeons with exceptional versatility through cutting-edge technology.
Source: https://www.businesswire.com/news/home/20231031697414/en/X%C4%93nix-Medical-Receives-FDA-Clearance-of-SOLACE%E2%84%A2-Sacroiliac-Fixation-System-with-NANOACTIV%E2%84%A2-Nanotechnology
