510(k) Report

Devices descending from K042201

796 later devices reach Novel VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+1K061752Spinal Usa VBR SystemSpinal USA20060—
+1K052170Seaspine VBR SystemSeaspine, Inc.200513—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+2K071726ZUMASeaspine, Inc.200712—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+3K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+3K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K124034Mectalif AnteriorMedacta International201311—
+3K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113478Plif CageEisertech, LLC2012269—
+3K112862Mecta-CMedacta International201114—
+3K110915Cervical CageEisertech, LLC201123—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K1803473d CageFims Co., Ltd.20190—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+4K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K131178Idys Lif CagesClariance201311—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+4K122444Cervical CageEisertech, LLC201222—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243670Idys® LIFClariance20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K230583Tryptik TiSpineart SA20231—