510(k) Report

Devices descending from K111801

240 later devices reach Simmetry (TM) Sacroiliac Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+3K173752SI Screw SystemZavation Medical Products, LLC20180—
+3K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+4K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250647SImmetry+ SystemSivantage20250—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+4K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+4K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+4K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+5K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+5K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—