510(k) Report

Devices descending from K110512

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K213815SiJoin®T3Vgi Medical, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+4K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+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
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+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—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+5K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+5K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+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—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—