510(k) Report

Devices descending from K853033

696 later devices reach Hartshill Rect & Wires, Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+6K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+6K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+6K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+6K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+6K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240392JAZZ Spinal SystemImplanet20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232167VySpan™ PCT SystemVy Spine, LLC20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+7K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+7K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+7K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+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—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+7K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+7K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+7K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+7K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K150753OASYS SystemStryker Corporation201534—