510(k) Report

Devices descending from K010576

596 later devices reach Monarch Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+3K120469Erisma-LPClariance20126—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120899Range Spinal System, Unit RodK2m, Inc.201235—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691