510(k) Report

Devices descending from K021335

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+6K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+6K121728Tiger Spine SystemCorelink, LLC201250—
+6K121172Reform Pedicle Screw SystemSpinal USA201233—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K120696Tiger Spine SystemCorelink, LLC201241—
+6K080767Conquest Spinal SystemLife Spine200821—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—