510(k) Report

Devices descending from K052385

253 later devices reach Tangors Polyaxial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K131784Range Spinal SystemK2m, Inc.201334—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—