510(k) Report

Devices descending from K130092

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+1K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+1K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K230817TORPEDO Implant System®Deltacor GmbH20240—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+2K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+2K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+2K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+2K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+2K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+2K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K250647SImmetry+ SystemSivantage20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+3K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+3K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+3K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+7K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—