510(k) Report

Devices descending from K042524

373 later devices reach Modification to Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223852VySpan™ PCT SystemVy Spine, LLC20231—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K173508Everest Spinal SystemK2m20189—
+6K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K161149PASS OCT Spinal SystemMedicrea International SA20160—
+6K160756PASS OCT Spinal SystemMedicrea International SA20160—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K153169PASS OCT Patient Specific RodsMedicrea International20164—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133402K2M Modular HooksK2m, Inc.20140—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232167VySpan™ PCT SystemVy Spine, LLC20230—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K151216Everest Spinal SystemK2m, Inc.201511—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—