Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) → OUR — Sacroiliac Joint Fixation # OUR · Sacroiliac Joint Fixation _Orthopedic · 21 CFR 888.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR ## Overview - **Product Code:** OUR - **Device Name:** Sacroiliac Joint Fixation - **Regulation:** [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 131) Showing 20 most recent of 131 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260477](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K260477.md) | CATAMARAN™ SI Joint Fusion System | Tenon Medical | Apr 8, 2026 | SESE | | [K253488](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K253488.md) | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | Feb 11, 2026 | SESE | | [K253611](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K253611.md) | Falco Fusion System | Mcnicoll Surgical, Inc. | Jan 29, 2026 | SESE | | [K252834](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K252834.md) | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | Jan 28, 2026 | SESE | | [K251365](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K251365.md) | OptumSI Implant System | Si Solutions, LLC | Nov 20, 2025 | SESE | | [K252322](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K252322.md) | SIros-X System | Genesys Spine | Oct 22, 2025 | SESE | | [K253094](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K253094.md) | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | Oct 9, 2025 | SESE | | [K250894](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250894.md) | Eminent Spine Posterior SI System | Eminent Spine | Oct 7, 2025 | SESE | | [K250647](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250647.md) | SImmetry+ System | Sivantage | Jul 29, 2025 | SESE | | [K250247](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250247.md) | panaSIa SI Fusion System | Wenzel Spine, Inc. | Jul 9, 2025 | SESE | | [K251395](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K251395.md) | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA, Inc. | Jun 26, 2025 | SESE | | [K251525](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K251525.md) | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | Jun 6, 2025 | SESE | | [K242431](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K242431.md) | Omnia Medical PsiF DNA™ System | Omnia Medical, LLC | Jun 6, 2025 | SESE | | [K250001](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250001.md) | Patriot SI Implant System | Spinal Simplicity, LLC | Jun 3, 2025 | SESE | | [K251075](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K251075.md) | DYNAMIS™ Implant System | Promethean Restorative, LLC | Apr 25, 2025 | SESE | | [K250403](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250403.md) | Catamaran SI Joint Fusion System | Tenon Medical | Mar 21, 2025 | SESE | | [K243838](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K243838.md) | NEXXT MATRIXX® SI System | Nexxt Spine | Mar 14, 2025 | SESE | | [K243565](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K243565.md) | DYNAMIS™ SI Screw System | Promethean Restorative, LLC | Feb 28, 2025 | SESE | | [K243835](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K243835.md) | TiLink-P SI Joint Fusion System | SurGenTec, LLC | Dec 27, 2024 | SESE | | [K242414](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K242414.md) | TiLink-P Joint Fusion System | SurGenTec, LLC | Nov 21, 2024 | SESE | ## Top Applicants - SI-BONE, Inc. — 27 clearances - SurGenTec, LLC — 6 clearances - Zyga Technology, Inc. — 6 clearances - Life Spine, Inc. — 5 clearances - Orthofix, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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