510(k) Report

Devices descending from K021335

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+7K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K131343Reform Pedicle Screw SystemSpinal USA201331—
+7K130279Reform Pedicle Screw SystemSpinal USA201331—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K111953Nautilus Spinal SystemLife Spine20123—
+7K090320Conquest Spinal SystemLife Spine20092—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—