510(k) Report

Devices descending from K111792

470 later devices reach Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+1K172480icotec Interbody Cage SystemIcotec AG20185—
+1K123758Tasmin RSignus Medizintechnik GmbH20141—
+1K131372Mobis IISignus Medizintechnik GmbH2013462—
+1K122317Tetris IISignus Medizintechnik GmbH20122—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K192897icotec Cervical CageIcotec AG20201—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K153621Juliet® TiSpineart2016751
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K261049Scala® TLSpineart SA20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K200312Tryptik TiSpineart20202—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181818Scarlet AL-TSpineart201864—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K181203Juliet TiSpineart20181—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173702Juliet Ti LLSpineart20182—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—