510(k) Report

Devices descending from K110512

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+1K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+2K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+2K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+2K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+2K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+2K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+2K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+2K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+2K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+2K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201385—
+2K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+2K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K230817TORPEDO Implant System®Deltacor GmbH20240—
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231831TiLink-L Joint Fusion SystemSurgentec20232—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+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—
+3K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+3K173752SI Screw SystemZavation Medical Products, LLC20180—
+3K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+3K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+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—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+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—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250647SImmetry+ SystemSivantage20250—
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—