510(k) Report

Devices descending from K102907

245 later devices reach Simmetry Sacroiliac Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+4K173752SI Screw SystemZavation Medical Products, LLC20180—
+4K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+4K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+5K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250647SImmetry+ SystemSivantage20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+5K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+5K213815SiJoin®T3Vgi Medical, Inc.20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+5K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+5K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+5K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+6K182983iFuse Implant System®SI-BONE, Inc.201871—