510(k) Report

Devices descending from K131405

133 later devices reach Ifuse Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+1K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+1K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+1K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+1K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+1K151718iFuse Implant SystemSI-BONE, Inc.201585—
+1K150875iFuse Implant SystemSI-BONE, Inc.201586—
+1K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+1K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+1K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+2K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+2K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+2K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+2K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+2K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+2K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+2K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+2K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+2K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+2K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+2K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+2K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+2K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+2K213815SiJoin®T3Vgi Medical, Inc.20230—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+2K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+2K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+2K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+2K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+2K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+2K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+3K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K241895Cannulated PsiFGuardSpineguard20240—
+3K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+3K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+3K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+3K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+3K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+3K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+3K182983iFuse Implant System®SI-BONE, Inc.201871—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+4K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+4K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—