510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K1803473d CageFims Co., Ltd.20190—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K190488ProLift Expandable SystemLife Spine, Inc.201916—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181963ostaPek Interbody Fusion CagesColigne AG20181—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181397DualXInnovasive, Inc.201815—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+6K172568CervagePrecifit Medical, Ltd.20181—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K173128Alamo® CAlliance Partners, LLC20182—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—