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Sacroiliac Joint Fixation
FDA product code OUR · Class 2 · Orthopedic
7,424
Registered devices
1,410
Adverse events
2
Recalls
132
510(k) clearances
Devices with this code
SI-LOK — GLOBUS MEDICAL, INC.ASNIS — Stryker GmbHSIros-X — Genesys Orthopedics Systems LLCSacroFuse — SPINEFRONTIER, INC.ARx SAI — Life Spine, Inc.ZESPIN SI Joint Fusion System — Aegis Spine, Inc.iFuse Granite-Closed Head Implant System — Si-Bone Inc.ASNIS — Stryker GmbHSI-LOK — GLOBUS MEDICAL, INC.Xenix Medical Sacroiliac Fixation System — XENIX MEDICAL LLCCASSATT SIJ Fixation System — CTL Medical CorporationASNIS — Stryker GmbHASNIS — Stryker GmbHSacroiliac Joint Fusion System — Genesys Orthopedics Systems LLCPathLoc SI Joint Fusion System — L&K BIOMED CO. ,LTD.SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.ARx SAI — Life Spine, Inc.ARx SAI — Life Spine, Inc.Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLCASNIS — Stryker GmbHM.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International SASimmetry — Sivantage, Inc.SIros-X — Genesys Orthopedics Systems LLCNEXXT MATRIXX® SI System — NEXXT SPINE, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | SI-BONE, Inc. | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
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