510(k) Report

Devices descending from K112028

238 later devices reach SI-Lok Sacroiliac Joint Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+1K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+1K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+1K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+1K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+1K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+1K171651Excelsius GPSGlobus Medical, Inc.2017691
+1K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+1K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+1K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+1K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+1K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+1K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+1K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+1K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+1K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+2K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+2K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+2K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+2K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+2K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+2K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+2K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+2K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+2K240160EGPS Navigated InstrumentsAstura Medical20240—
+2K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+2K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+2K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+2K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K230817TORPEDO Implant System®Deltacor GmbH20240—
+2K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+2K231831TiLink-L Joint Fusion SystemSurgentec20232—
+2K223558CUVIS-spineCurexo, Inc.20230—
+2K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+2K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+2K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K201569CUVIS-spineCurexo, Inc.20212—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+2K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+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—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+2K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+2K173752SI Screw SystemZavation Medical Products, LLC20180—
+2K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+2K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+2K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+2K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+3K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+3K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K250647SImmetry+ SystemSivantage20250—
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+3K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+3K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—