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.
FDA 510(k) Cleared Sacroiliac Joint Fixation Devices (Product Code OUR)
About Product Code OUR - Regulatory Context
510(k) Submission Activity
131 total 510(k) submissions under product code OUR since 2005, with 131 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 26 submissions in the last 24 months compared to 39 in the prior period.
FDA Review Time
Recent submissions under OUR have taken an average of 94 days to reach a decision - down from 128 days historically, suggesting improved FDA processing for this classification.
OUR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →