510(k) Report

Devices descending from K092375

255 later devices reach Modification to SI Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+3K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+3K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011240—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231831TiLink-L Joint Fusion SystemSurgentec20232—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+4K190230iFuse Implant System®SI-BONE, Inc.201957—
+4K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+4K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+4K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+4K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+4K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+4K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201385—
+4K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+5K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+5K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+5K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.201814—
+5K173752SI Screw SystemZavation Medical Products, LLC20180—
+5K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—