FDA Product Code OUR: Sacroiliac Joint Fixation

Under FDA product code OUR, sacroiliac joint fixation devices are cleared for the surgical stabilization and fusion of the sacroiliac joint.

The sacroiliac joint connects the spine to the pelvis and is a significant source of lower back and buttock pain. OUR devices — typically minimally invasive implant systems of screws or rods — immobilize the joint to promote bone fusion and relieve chronic pain unresponsive to conservative treatment.

OUR devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include SI-BONE, Inc., SurGenTec, LLC and Spinal Simplicity, LLC.