510(k) Report

Devices descending from K052761

735 later devices reach Modification to: Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+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—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172469TiLock Modular Spinal SystemGenesys Spine20170—
+7K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+7K171321K2M Navigation InstrumentsK2m201711
+7K172194Connector SystemOrthofix, Inc.2017162
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+7K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+7K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+7K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K153404Zavation Spinal SystemZavation, LLC20161—
+7K151977icotec Pedicle SystemIcotec AG201630—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+7K141850Flospine Pedicle Screw SystemFlospine20140—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+7K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+7K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+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—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250637VCFix Spinal SystemAmber Implants20250—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—