510(k) Report

Devices descending from K102907

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162121Siconus SI Joint Fixation SystemCamber Spine Technologies20171—
+1K123702Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201349—
+1K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011241—
+2K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K170475SICAGE™ SystemSicage, LLC20170—
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+2K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+2K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+2K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+3K252322SIros-X SystemGenesys Spine20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+3K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+3K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+3K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+3K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+3K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+3K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+3K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+3K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+3K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+3K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201385—
+3K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+3K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230817TORPEDO Implant System®Deltacor GmbH20240—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231831TiLink-L Joint Fusion SystemSurgentec20232—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+4K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+4K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—