510(k) Report

Devices descending from K123702

49 later devices reach Silex Sacroiliac Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+1K170475SICAGE™ SystemSicage, LLC20170—
+1K162121Siconus SI Joint Fixation SystemCamber Spine Technologies20171—
+1K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+1K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+1K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K252322SIros-X SystemGenesys Spine20250—
+2K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+2K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+2K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+2K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+2K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+2K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+2K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+2K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+2K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+2K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+2K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+3K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+3K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+3K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+3K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+3K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+4K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—