510(k) Report

Devices descending from K042789

325 later devices reach Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K231654NorthStar OCT SystemSeaspine, Inc.20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230614Cortium™Ulrich Medical USA20230—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131427LOTUSSpinal Elements, Inc.20130—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+4K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+4K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+4K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+4K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+5K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—