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
+7K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+7K131784Range Spinal SystemK2m, Inc.201334—
+7K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+7K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+7K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+7K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+7K121728Tiger Spine SystemCorelink, LLC201250—
+7K121172Reform Pedicle Screw SystemSpinal USA201233—
+7K121020Viper SystemDepuy Spine, Inc.201294—
+7K120696Tiger Spine SystemCorelink, LLC201241—
+7K080767Conquest Spinal SystemLife Spine200821—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K253249TriALTIS™ Spine SystemMedos International SARL20251—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+8K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+8K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+8K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+8K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+8K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+8K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+8K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+8K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+8K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+8K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+8K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+8K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+8K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+8K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+8K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+8K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+8K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+8K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+8K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+8K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—