Xenix Medical Receives FDA Approval for SOLACE™ Sacroiliac Fixation System

Orlando, FL-based Xenix Medical has received U.S. FDA 510(k) clearance for the SOLACE™️ Sacroiliac Fixation System, which 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 SOLACE Sacroiliac Fixation System consists of 3D printed threaded implants with diameters of 10.5mm or 12.0mm and lengths of 30mm to 115mm. The implants feature Xenix Medical’s NANOACTIV nanotechnology surface and incorporate helical autograft harvesting flutes and porous channels for bone ingrowth along the length of the device.

The system is also cleared for navigation of the SOLACE implants and instruments using the Medtronic® StealthStation® system and NavLock® trackers to assist the surgeon in precisely locating anatomical structures during open or minimally invasive procedures.

The SOLACE Sacroiliac Fixation System is the only nanotechnology sacroiliac fixation system on the market designed specifically for a lateral, oblique or posterior sacral alar iliac technique, giving surgeons complete versatility with a best-in-class technology platform,” stated Ryan Phillips, President of Xenix Medical.

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