BEUDAMED
    Product Code: OUR FDA class 2 21 CFR 888.3040

    Sacroiliac Joint Fixation

    Orthopedic

    The Sacroiliac Joint Fixation device (product code OUR) is an implantable orthopedic system used for sacroiliac joint fusion, indicated for patients with sacroiliac joint dysfunction causing chronic lower back or pelvic pain. It stabilizes the sacroiliac joint to promote bony fusion and pain relief. As an FDA Class 2 device under regulation 888.3040, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    131
    FEI Numbers
    155
    Registration Numbers
    155
    Unique Applicants
    63
    Years Active
    21

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    Basic Information

    Product Code
    OUR
    Device Class
    FDA class 2
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    sacroiliac joint fusion

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 131 510(k) clearances via K numbers.

    K Number Device Name
    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
    K251525 SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
    K242431 Omnia Medical PsiF DNA™ 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
    K162733 iFuse Implant System® - iFuse-3D implant
    K162121 Siconus SI Joint Fixation System
    K161755 Integrity-SI TM Fusion System
    K153656 PathLoc-SI Joint Fusion System
    K161210 RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
    K160652 iFUSE Implant System
    K152681 iFuse Implant System(R)
    K152237 The Entasis Dual-Lead Sacroiliac Implant
    K151718 iFuse Implant System
    K151462 SI-TECHNOLOGY® SI-DESIS® SCREWS
    K151818 SImmetry Sacroiliac Joint Fusion System
    K150875 iFuse Implant System
    K150017 SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
    K150714 SI-BONE iFuse Implant System
    K141246 LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
    K141549 SImmetry Sacroiliac Joint Fusion System
    K141106 FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
    K141049 IFUSE IMPLANT SYSTEM
    K140079 SILEX SACROILIAC JOINT FUSION SYSTEM
    K131405 IFUSE IMPLANT SYSTEM
    K123850 IFUSE IMPLANT SYSTEM
    K123702 SILEX SACROILIAC JOINT FUSION SYSTEM
    K130092 SIMMETRY SACROILIAC JOINT FUSION SYSTEM
    K122074 IFUSE IMPLANT SYSTEM
    K110472 SI-FIX SACROILIAC JOINT FUSION SYSTEM
    K111801 SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
    K110838 IFUSE IMPLANT SYSTEM
    K110512 SIMMETRY SACROILIAC JOINT FUSION SYSTEM
    K102907 SIMMETRY SACROILIAC JOINT FUSION SYSTEM
    K092375 MODIFICATION TO SI JOINT FUSION SYSTEM
    K080398 SI JOINT FUSION SYSTEM
    K051296 SIJF CANNULATED SCREW SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 155 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 155 registration numbers. Click on an entry to view related FDA registrations.