510(k) Report

Devices descending from K010576

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K162367Erisma® LP MISClariance, Sas20162—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421