
Xēnix Medical Receives FDA Clearance for Innovative SOLACE Sacroiliac Fixation System Using Proprietary NANOACTIV Surface Technology
11-1-23 (by: Scott Gleason) Xēnix Medical has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its SOLACE™️ Sacroiliac Fixation System. The company’s system incorporates its proprietary NANOACTIV™️ surface technology and is compatible with the StealthStation® Navigation system from Medtronic (a fluoroscopy imaging system for surgery). Iliosacral screw fixation is a fluoroscopically guided, percutaneous procedure. Its primary use is for fixation of satisfactorily reduced sacro-iliac joint disruptions to alleviate pain along with fusion procedures or sacral fractures. There are about 6,300 sacral fractures in the U.S. every year. They are common in elderly patients with osteoporosis or in high trauma situations.
The company’s SOLACE Sacroiliac Fixation System is comprised of 3D printed, threaded implants with diameters ranging from 10.5mm to 12.0mm and lengths spanning 30mm to 115mm. These implants are equipped with Xēnix Medical’s revolutionary NANOACTIV nanotechnology surface to encourage osteogenesis. They feature helical autograft harvesting flutes and porous channels for bone ingrowth along the device’s length. The primary applications of the SOLACE Sacroiliac Fixation System include sacroiliac fusion for sacroiliac joint dysfunction, such as degenerative sacroiliitis and sacroiliac joint disruptions. It is also designed for augmenting, immobilizing, and stabilizing the sacroiliac joint in skeletally mature patients who require sacropelvic fixation as part of a lumbar or thoracolumbar fusion. Furthermore, it is cleared for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
Dr. Todd Abel, a Neurosurgeon at the University of Tennessee Medical Center in Knoxville, Tennessee, expressed his excitement about the SOLACE SI System. “I am extremely excited about the implant nano surface features and ease of use of the Solace SI System. I believe my patients will have improved fusion rates and improved patient outcomes and quality of life from the NANOACTIV surface.”