510(k) Report

Devices descending from K113561

476 later devices reach TM Ardis Interbody System TM Ardis Interbody System Instrumenation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+1K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+1K150481Cascadia Interbody SystemK2m, Inc.20154593
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+1K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+2K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+2K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K153621Juliet® TiSpineart2016751
+2K160125Cascadia Interbody SystemK2m2016315—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K261049Scala® TLSpineart SA20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181818Scarlet AL-TSpineart201864—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K181203Juliet TiSpineart20181—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173702Juliet Ti LLSpineart20182—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—