510(k) Report

Devices descending from K990965

672 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+6K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150753OASYS SystemStryker Corporation201534—
+6K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+6K121728Tiger Spine SystemCorelink, LLC201250—
+6K121172Reform Pedicle Screw SystemSpinal USA201233—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K120696Tiger Spine SystemCorelink, LLC201241—
+6K080767Conquest Spinal SystemLife Spine200821—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—