510(k) Report

Devices descending from K072120

1,405 later devices reach Paramount Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K202380Born PT-LIF Cage HASpineworxx AG20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200312Tryptik TiSpineart20202—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192993Scarlet AL-TSpineart20201—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+4K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+4K183064TxTi IBF SystemInnovasis, Inc.2019481
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181818Scarlet AL-TSpineart201864—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K181203Juliet TiSpineart20181—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+4K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—