Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OUR — Predicate Candidate Screening
131 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
263 days90th percentile
131clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260477 | CATAMARAN™ SI Joint Fusion System | Tenon Medical | 2026-04-08 | 55 | 0 |
| K253488 | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | 2026-02-11 | 110 | 0 |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026-01-29 | 72 | 0 |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | 2026-01-28 | 145 | 0 |
| K251365 | OptumSI Implant System | Si Solutions, LLC | 2025-11-20 | 203 | 0 |
| K252322 | SIros-X System | Genesys Spine | 2025-10-22 | 89 | 0 |
| K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2025-10-09 | 16 | 0 |
| K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025-10-07 | 196 | 0 |
| K250647 | SImmetry+ System | Sivantage | 2025-07-29 | 147 | 0 |
| K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | 2025-07-09 | 163 | 0 |
| K251395 | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 | 52 | 0 |
| K242431 | Omnia Medical PsiF DNA™ System | Omnia Medical, LLC | 2025-06-06 | 294 | 0 |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025-06-06 | 18 | 0 |
| K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | 2025-06-03 | 152 | 0 |
| K251075 | DYNAMIS™ Implant System | Promethean Restorative, LLC | 2025-04-25 | 17 | 0 |
| K250403 | Catamaran SI Joint Fusion System | Tenon Medical | 2025-03-21 | 37 | 0 |
| K243838 | NEXXT MATRIXX® SI System | Nexxt Spine | 2025-03-14 | 91 | 0 |
| K243565 | DYNAMIS™ SI Screw System | Promethean Restorative, LLC | 2025-02-28 | 102 | 0 |
| K243835 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-12-27 | 14 | 0 |
| K242414 | TiLink-P Joint Fusion System | SurGenTec, LLC | 2024-11-21 | 99 | 0 |
| K242141 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-08-21 | 30 | 0 |
| K241504 | iFuse TORQ TNT™ Implant System | SI-BONE, Inc. | 2024-08-19 | 83 | 0 |
| K241813 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2024-08-13 | 53 | 0 |
| K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024-07-29 | 67 | 0 |
| K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024-07-02 | 29 | 0 |
| K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024-06-04 | 104 | 0 |
| K232149 | BowTie™ SI Joint Fusion System | Sail Fusion, LLC | 2024-04-20 | 276 | 0 |
| K232259 | Patriot-SI Posterior Implant System | Spinal Simplicity, LLC | 2024-04-19 | 263 | 0 |
| K240720 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-04-11 | 27 | 0 |
| K233972 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies | 2024-02-27 | 74 | 0 |
| K240201 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2024-02-23 | 29 | 0 |
| K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024-01-26 | 87 | 0 |
| K230817 | TORPEDO Implant System® | Deltacor GmbH | 2024-01-19 | 301 | 0 |
| K231923 | Liberty SI Lateral Implant System | Spinal Simplicity, LLC | 2023-12-05 | 158 | 0 |
| K233241 | SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical | 2023-10-27 | 29 | 0 |
| K232211 | REUNION Sacroiliac Joint Fusion System | Astura Medical | 2023-10-24 | 90 | 0 |
| K232878 | TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) | 2023-10-17 | 29 | 0 |
| K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® Screw | Lesspine Innovations | 2023-09-28 | 31 | 0 |
| K230857 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2023-09-25 | 180 | 0 |
| K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023-09-21 | 237 | 0 |
| K231944 | CATAMARAN SI Joint Fusion System | Tenon Medical, Inc. | 2023-08-24 | 55 | 0 |
| K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | 2023-08-15 | 55 | 0 |
| K231831 | TiLink-L Joint Fusion System | Surgentec | 2023-08-03 | 42 | 0 |
| K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023-07-28 | 28 | 0 |
| K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023-07-14 | 22 | 0 |
| K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023-06-30 | 21 | 0 |
| K230446 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | 2023-06-07 | 106 | 0 |
| K220274 | Kisar Stratford SI Screw System | Anjali Investments L.L.C | 2023-04-24 | 448 | 0 |
| K230689 | T-FIX™ 3DSI Joint Fusion System | Cutting Edge Spine, LLC | 2023-04-05 | 23 | 0 |
| K213815 | SiJoin®T3 | Vgi Medical, Inc. | 2023-03-29 | 477 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda