Orthopedic

OUR · Sacroiliac Joint Fixation

Orthopedic · 21 CFR 888.3040 · Class 2

Overview

Product CodeOUR
Device NameSacroiliac Joint Fixation
Regulation21 CFR 888.3040
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

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.

Cleared Devices (131)

RecordDevice NameApplicantDecision DateDecision
K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalApr 8, 2026SESE
K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.Feb 11, 2026SESE
K253611Falco Fusion SystemMcnicoll Surgical, Inc.Jan 29, 2026SESE
K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalJan 28, 2026SESE
K251365OptumSI Implant SystemSi Solutions, LLCNov 20, 2025SESE
K252322SIros-X SystemGenesys SpineOct 22, 2025SESE
K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.Oct 9, 2025SESE
K250894Eminent Spine Posterior SI SystemEminent SpineOct 7, 2025SESE
K250647SImmetry+ SystemSivantageJul 29, 2025SESE
K250247panaSIa SI Fusion SystemWenzel Spine, Inc.Jul 9, 2025SESE
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.Jun 26, 2025SESE
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLCJun 6, 2025SESE
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLCJun 6, 2025SESE
K250001Patriot SI Implant SystemSpinal Simplicity, LLCJun 3, 2025SESE
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLCApr 25, 2025SESE
K250403Catamaran SI Joint Fusion SystemTenon MedicalMar 21, 2025SESE
K243838NEXXT MATRIXX® SI SystemNexxt SpineMar 14, 2025SESE
K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLCFeb 28, 2025SESE
K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLCDec 27, 2024SESE
K242414TiLink-P Joint Fusion SystemSurGenTec, LLCNov 21, 2024SESE
K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLCAug 21, 2024SESE
K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.Aug 19, 2024SESE
K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLCAug 13, 2024SESE
K241464ARx® SAI Implant SystemLife Spine, Inc.Jul 29, 2024SESE
K241574iFuse TORQ® Implant SystemSI-BONE, Inc.Jul 2, 2024SESE
K240505Eminent Spine SI Screw SystemEminent Spine, LLCJun 4, 2024SESE
K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLCApr 20, 2024SESE
K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLCApr 19, 2024SESE
K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLCApr 11, 2024SESE
K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine TechnologiesFeb 27, 2024SESE
K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.Feb 23, 2024SESE
K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.Jan 26, 2024SESE
K230817TORPEDO Implant System®Deltacor GmbHJan 19, 2024SESE
K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLCDec 5, 2023SESE
K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix MedicalOct 27, 2023SESE
K232211REUNION Sacroiliac Joint Fusion SystemAstura MedicalOct 24, 2023SESE
K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)Oct 17, 2023SESE
K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation SystemLesspine InnovationsSep 28, 2023SESE
K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLCSep 25, 2023SESE
K230226Integrity-SI® Fusion SystemOsteoCentric TechnologiesSep 21, 2023SESE
K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.Aug 24, 2023SESE
K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix MedicalAug 15, 2023SESE
K231831TiLink-L Joint Fusion SystemSurgentecAug 3, 2023SESE
K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLCJul 28, 2023SESE
K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.Jul 14, 2023SESE
K231689iFuse TORQ® Implant SystemSI-BONE, Inc.Jun 30, 2023SESE
K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLCJun 7, 2023SESE
K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.CApr 24, 2023SESE
K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLCApr 5, 2023SESE
K213815SiJoin®T3Vgi Medical, Inc.Mar 29, 2023SESE
K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLCMar 21, 2023SESE
K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.Jan 20, 2023SESE
K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLCJan 18, 2023SESE
K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.Dec 22, 2022SESE
K211785CASSATT™ SIJ Fixation SystemCtl Medical CorporationOct 17, 2022SESE
K222448UNITY Sacroiliac Joint Fixation SystemDio Medical CorporationOct 13, 2022SESE
K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.Oct 3, 2022SESE
K222605iFuse TORQ® Implant SystemSI-BONE, Inc.Sep 29, 2022SESE
K222512Integrity-SI Fusion SystemOsteoCentric TechnologiesSep 12, 2022SESE
K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLCSep 2, 2022SESE
K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)Jul 27, 2022SESE
K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine, Inc.Jun 30, 2022SESE
K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLCJun 24, 2022SESE
K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.Jun 10, 2022SESE
K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.May 26, 2022SESE
K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLCApr 11, 2022SESE
K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLCMar 1, 2022SESE
K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.Dec 15, 2021SESE
K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.Sep 9, 2021SESE
K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLCAug 31, 2021SESE
K210667FIREBIRD SI Fusion SystemOrthofix, Inc.Mar 25, 2021SESE
K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.Mar 23, 2021SESE
K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.Feb 25, 2021SESE
K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis SpineFeb 16, 2021SESE
K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLCJan 22, 2021SESE
K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.Jan 13, 2021SESE
K203138FIREBIRD SI Fusion SystemOrthofix, Inc.Nov 18, 2020SESE
K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.Sep 18, 2020SESE
K201664FIREBIRD SI Fusion SystemOrthofix, Inc.Sep 15, 2020SESE
K190580NADIA SI Fusion SystemIlion Medical, Inc.Aug 5, 2020SESE
K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion MedicalApr 17, 2020SESE
K200696FIREBIRD SI Fusion SystemOrthofix, Inc.Apr 2, 2020SESE
K193524SI-BONE iFuse Implant System®SI-BONE, Inc.Mar 31, 2020SESE
K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.Dec 3, 2019SESE
K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys SpineSep 26, 2019SESE
K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLCAug 12, 2019SESE
K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.Apr 30, 2019SESE
K190230iFuse Implant System®SI-BONE, Inc.Apr 3, 2019SESE
K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® InstrumentsGlobus Medical, Inc.Feb 6, 2019SESE
K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion MedicalJan 25, 2019SESE
K182983iFuse Implant System®SI-BONE, Inc.Nov 27, 2018SESE
K181881Outlet Sacroiliac Joint Fusion SystemSij SurgicalOct 3, 2018SESE
K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.Jul 16, 2018SESE
K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.Jun 15, 2018SESE
K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.Jun 13, 2018SESE
K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co. , Ltd.Apr 26, 2018SESE
K173752SI Screw SystemZavation Medical Products, LLCMar 16, 2018SESE
K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.Aug 2, 2017SESE
K170475SICAGE™ SystemSicage, LLCMay 5, 2017SESE
K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.Mar 10, 2017SESE
K162121Siconus SI Joint Fixation SystemCamber Spine TechnologiesJan 18, 2017SESE
K161755Integrity-SI TM Fusion SystemCoorstek MedicalDec 14, 2016SESE
K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.Nov 14, 2016SESE
K161210RIALTO(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) SystemsMedtronic Sofamor DanekAug 12, 2016SESE
K160652iFUSE Implant SystemSI-BONE, Inc.Jun 3, 2016SESE
K152681iFuse Implant System(R)SI-BONE, Inc.Mar 1, 2016SESE
K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLCFeb 4, 2016SESE
K151718iFuse Implant SystemSI-BONE, Inc.Oct 29, 2015SESE
K151462SI-TECHNOLOGY® SI-DESIS® SCREWSSi-Technology, LLCAug 12, 2015SESE
K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.Aug 5, 2015SESE
K150875iFuse Implant SystemSI-BONE, Inc.Jul 22, 2015SESE
K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.Apr 24, 2015SESE
K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.Apr 17, 2015SESE
K141246LIFE SPINE SACROILIAC JOINT FIXATION SYSTEMLife Spine, Inc.Feb 22, 2015SESE
K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.Jan 15, 2015SESE
K141106FRONTIER DEVICES FUSIO SCREW FUZE SYSTEMFolsom Metal Products, Inc. Dba Frontier DevicesOct 10, 2014SESE
K141049IFUSE IMPLANT SYSTEMSI-BONE, Inc.Jul 23, 2014SESE
K140079SILEX SACROILIAC JOINT FUSION SYSTEMX-Spine Systems, Inc.Mar 25, 2014SESE
K131405IFUSE IMPLANT SYSTEMSI-BONE, Inc.Oct 16, 2013SESE
K123850IFUSE IMPLANT SYSTEMSI-BONE, Inc.Apr 1, 2013SESE
K123702SILEX SACROILIAC JOINT FUSION SYSTEMX-Spine Systems, Inc.Mar 11, 2013SESE
K130092SIMMETRY SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.Feb 27, 2013SESE
K122074IFUSE IMPLANT SYSTEMSI-BONE, Inc.Oct 12, 2012SESE
K110472SI-FIX SACROILIAC JOINT FUSION SYSTEMMedtronic Sofamor DanekMay 29, 2012SESE
K111801SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.Jul 21, 2011SESE
K110838IFUSE IMPLANT SYSTEMSI-BONE, Inc.Apr 21, 2011SESE
K110512SIMMETRY SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.Mar 23, 2011SESE
K102907SIMMETRY SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.Dec 14, 2010SESE
K092375MODIFICATION TO SI JOINT FUSION SYSTEMSI-BONE, Inc.Sep 4, 2009SESE
K080398SI JOINT FUSION SYSTEMSI-BONE, Inc.Nov 26, 2008SESE
K051296SIJF CANNULATED SCREW SYSTEMDepuy Spine, Inc.Aug 26, 2005SESE

Top Applicants

Innolitics

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