510(k) Report

Devices descending from K021335

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+4K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+4K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K162367Erisma® LP MISClariance, Sas20162—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671