The FDA on Jan. 31 gave Alevio Spine additional 510(k) clearance for the devicemaker's SI-Cure sacroiliac joint fusion system.
The added indications include sacroiliac fusion for skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or lumbar or thoracolumbar spinal fusion, according to a news release. Clinical studies found the SI-Cure system can decrease the risk of disability and prevent the development of postoperative SI joint pain.
The device was previously cleared for SI fusion for sacroiliac joint dysfunction and fractures involving the sacroiliac joint.