Product code OUR— Orthopedic
IFUSE IMPLANT SYSTEM
- Classification name
- Sacroiliac Joint Fixation
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Total cleared
- 132
- First cleared
- Most recent
FDA classification definition
“sacroiliac joint fusion”
Market context for product code OUR
FDA has cleared devices under product code OUR between 2005 and 2026, filed by 63 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code OUR
Adverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OUR
1–100 of 132- K261381 — TiLink-L SI Joint Fusion System
- K260477 — CATAMARAN SI Joint Fusion System
- K253488 — iFuse INTRA Ti Implant System
- K253611 — Falco Fusion System
- K252834 — Sacroiliac Joint Truss System (SJTS)
- K251365 — OptumSI Implant System
- K252322 — SIros-X System
- K253094 — iFuse Bedrock Granite Implant System
- K250894 — Eminent Spine Posterior SI System
- K250647 — SImmetry+ System
- K250247 — panaSIa SI Fusion System
- K251395 — The Rialto SI Fusion System
- K242431 — Omnia Medical PsiF DNA System
- K251525 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K250001 — Patriot SI Implant System
- K251075 — DYNAMIS Implant System
- K250403 — Catamaran SI Joint Fusion System
- K243838 — NEXXT MATRIXX® SI System
- K243565 — DYNAMIS SI Screw System
- K243835 — TiLink-P SI Joint Fusion System
- K242414 — TiLink-P Joint Fusion System
- K242141 — TiLink-P SI Joint Fusion System
- K241504 — iFuse TORQ TNT Implant System
- K241813 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K241464 — ARx® SAI Implant System
- K241574 — iFuse TORQ® Implant System
- K240505 — Eminent Spine SI Screw System
- K232149 — BowTie SI Joint Fusion System
- K232259 — Patriot-SI Posterior Implant System
- K240720 — TiLink-P SI Joint Fusion System
- K233972 — Camber Sacroiliac (SI) Fixation System
- K240201 — PathLoc SI Joint Fusion System
- K233508 — iFuse Bedrock Granite® Implant System
- K230817 — TORPEDO Implant System®
- K231923 — Liberty SI Lateral Implant System
- K233241 — SOLACE Sacroiliac Fixation System
- K232211 — REUNION Sacroiliac Joint Fusion System
- K232878 — TransLoc 3D
- K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
- K230857 — TiLink-P SI Joint Fusion System
- K230226 — Integrity-SI® Fusion System
- K231944 — CATAMARAN SI Joint Fusion System
- K231829 — Xenix Medical Sacroiliac Fixation System
- K231831 — TiLink-L Joint Fusion System
- K231951 — SI-Cure Sacroiliac Joint Fusion System
- K231841 — PathLoc SI Joint Fusion System
- K231689 — iFuse TORQ® Implant System
- K230446 — TiLink-L SI Joint Fusion System
- K220274 — Kisar Stratford SI Screw System
- K230689 — T-FIX 3DSI Joint Fusion System
- K213815 — SiJoin®T3
- K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System
- K223521 — ZESPIN SI Joint Fusion System
- K223819 — SI-Cure Sacroiliac Joint Fusion System
- K222774 — iFuse Bedrock Granite® Implant System
- K211785 — CASSATT SIJ Fixation System
- K222448 — UNITY Sacroiliac Joint Fixation System
- K221047 — SILO TFX MIS Sacroiliac Joint Fixation System
- K222605 — iFuse TORQ® Implant System
- K222512 — Integrity-SI Fusion System
- K203503 — Camber Sacroiliac (SI) Fixation System
- K211496 — TransLoc 3D
- K221050 — ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
- K214123 — T-FIX® 3DSI Joint Fusion System
- K213667 — iFuse-TORQ® Implant System
- K220195 — iFuse Bedrock Granite Implant System
- K212962 — TRELLIS SI Joint Fusion System
- K213590 — Blue Topaz Sacroiliac Screw System
- K212903 — SIMPACT Sacroiliac Joint Fixation System
- K210402 — Curiteva Sacroiliac Joint Fusion System
- K211449 — Triton Sacroiliac Joint Fixation System
- K210667 — FIREBIRD SI Fusion System
- K203780 — Harvester SI: Sacroiliac Fixation System
- K203247 — iFuse-TORQ Implant System
- K210035 — ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
- K203373 — Advanced Research Medical Trident SI Screw System
- K203671 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K203138 — FIREBIRD SI Fusion System
- K201538 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K201664 — FIREBIRD SI Fusion System
- K190580 — NADIA SI Fusion System
- K200868 — SI-Restore Sacroiliac Joint Fixation System
- K200696 — FIREBIRD SI Fusion System
- K193524 — SI-BONE iFuse Implant System®
- K193083 — M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
- K191748 — Genesys Spine Sacroiliac Joint Fusion System
- K190025 — EVOL® -SI Joint Fusion System
- K183342 — SambaScrew 3D SI Fusion System
- K190230 — iFuse Implant System®
- K183119 — SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
- K182919 — SI-Restore® Sacroiliac Joint Fixation System
- K182983 — iFuse Implant System®
- K181881 — Outlet Sacroiliac Joint Fusion System
- K181600 — PathLoc-SI Joint Fusion System
- K180749 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K180818 — Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
- K173201 — UNITY Sacroiliac Joint Fixation System
- K173752 — SI Screw System
- K171595 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K170475 — SICAGE System
Data sourced from openFDA. This site is unofficial and independent of the FDA.