510(k) Report

Devices descending from K003780

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+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—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200731—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+5K230614Cortium™Ulrich Medical USA20230—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+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—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+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—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+5K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—