OUR
- Product code
- OUR
- Device name
- Sacroiliac Joint Fixation
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3040
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 132
FDA classification definition
sacroiliac joint fusion
510(k) clearances, last 3 years (41)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261381 | 2026-08-24 | SurGenTec, LLC | TiLink-L SI Joint Fusion System | |
| K260477 | 2026-04-08 | Tenon Medical | CATAMARAN SI Joint Fusion System | |
| K253488 | 2026-02-11 | SI-BONE, Inc. | iFuse INTRA Ti Implant System | |
| K253611 | 2026-01-29 | Mcnicoll Surgical, Inc. | Falco Fusion System | |
| K252834 | 2026-01-28 | 4Web Medical | Sacroiliac Joint Truss System (SJTS) | |
| K251365 | 2025-11-20 | Si Solutions, LLC | OptumSI Implant System | |
| K252322 | 2025-10-22 | Genesys Spine | SIros-X System | |
| K253094 | 2025-10-09 | SI-BONE, Inc. | iFuse Bedrock Granite Implant System | |
| K250894 | 2025-10-07 | Eminent Spine | Eminent Spine Posterior SI System | |
| K250647 | 2025-07-29 | Sivantage | SImmetry+ System | |
| K250247 | 2025-07-09 | Wenzel Spine, Inc. | panaSIa SI Fusion System | |
| K251395 | 2025-06-26 | Medtronic Sofamor Danek USA, Inc. | The Rialto SI Fusion System | |
| K251525 | 2025-06-06 | Si-Technology, LLC | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion | |
| K242431 | 2025-06-06 | Omnia Medical, LLC | Omnia Medical PsiF DNA System | FDA |
| K250001 | 2025-06-03 | Spinal Simplicity, LLC | Patriot SI Implant System | |
| K251075 | 2025-04-25 | Promethean Restorative, LLC | DYNAMIS Implant System | |
| K250403 | 2025-03-21 | Tenon Medical | Catamaran SI Joint Fusion System | |
| K243838 | 2025-03-14 | Nexxt Spine | NEXXT MATRIXX® SI System | |
| K243565 | 2025-02-28 | Promethean Restorative, LLC | DYNAMIS SI Screw System | |
| K243835 | 2024-12-27 | SurGenTec, LLC | TiLink-P SI Joint Fusion System | |
| K242414 | 2024-11-21 | SurGenTec, LLC | TiLink-P Joint Fusion System | FDA |
| K242141 | 2024-08-21 | SurGenTec, LLC | TiLink-P SI Joint Fusion System | |
| K241504 | 2024-08-19 | SI-BONE, Inc. | iFuse TORQ TNT Implant System | |
| K241813 | 2024-08-13 | Si-Technology, LLC | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion | |
| K241464 | 2024-07-29 | Life Spine, Inc. | ARx® SAI Implant System | |
| K241574 | 2024-07-02 | SI-BONE, Inc. | iFuse TORQ® Implant System | |
| K240505 | 2024-06-04 | Eminent Spine, LLC | Eminent Spine SI Screw System | |
| K232149 | 2024-04-20 | Sail Fusion, LLC | BowTie SI Joint Fusion System | |
| K232259 | 2024-04-19 | Spinal Simplicity, LLC | Patriot-SI Posterior Implant System | |
| K240720 | 2024-04-11 | SurGenTec, LLC | TiLink-P SI Joint Fusion System | |
| K233972 | 2024-02-27 | Camber Spine Technologies | Camber Sacroiliac (SI) Fixation System | |
| K240201 | 2024-02-23 | L&K BIOMED Co., Ltd. | PathLoc SI Joint Fusion System | |
| K233508 | 2024-01-26 | SI-BONE, Inc. | iFuse Bedrock Granite® Implant System | |
| K230817 | 2024-01-19 | Deltacor GmbH | TORPEDO Implant System® | |
| K231923 | 2023-12-05 | Spinal Simplicity, LLC | Liberty SI Lateral Implant System | FDA |
| K233241 | 2023-10-27 | Ht Medical, LLC Dba Xenix Medical | SOLACE Sacroiliac Fixation System | |
| K232211 | 2023-10-24 | Astura Medical | REUNION Sacroiliac Joint Fusion System | |
| K232878 | 2023-10-17 | Foundation Fusion Solutions, LLC (Dba | TransLoc 3D | |
| K232605 | 2023-09-28 | Lesspine Innovations | Sacrix® Sacroiliac Joint Fusion Device System, Inspa | |
| K230857 | 2023-09-25 | SurGenTec, LLC | TiLink-P SI Joint Fusion System | |
| K230226 | 2023-09-21 | OsteoCentric Technologies | Integrity-SI® Fusion System |
Official FDA classification page: OUR
Classification and pathway per current FDA publications. Data from openFDA (CC0).