510(k) Report

Devices descending from K021335

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K120899Range Spinal System, Unit RodK2m, Inc.201235—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172194Connector SystemOrthofix, Inc.2017162