510(k) Report

Devices descending from K010576

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—