510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K073649Bengal Stackable Cage SystemDepuy Spine, Inc.2008278—
+1K041407Titanium Mesh ImplantInterpore Cross Intl.20040—
+1K041722Modification to VBR Spinal SystemDepuy Spine, Inc.20041,150—
+1K031635Depuy Acromed VBR SystemDepuyacromed20031,201—
+1K030833Depuy Acromed VBR SystemDepuyacromed20031,224—
+1K030249Surgical Titanium Mesh SystemDepuyacromed2003616—
+2K190284Bengal Stackable Cage SystemMedos International SARL20190—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K090566Pathway AvidCustom Spine, Inc.2009639—
+2K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+2K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009932—
+2K080568X-Mesh Expandable Cage SystemDepuy Spine, Inc.2008615—
+2K080281PathwayCustom Spine, Inc.2008188—
+2K053080Graftcage AcxOsteotech, Inc.20050—
+2K052746Concorde VBR Spinal SystemDepuy Spine, Inc.20051,149—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K173148ACIFColigne AG20171—
+3K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K160631Keos Lumbar IBFDKeos20161—
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K142030STGC-LordoticCardinal Spine, LLC201558—
+3K142016CAPRIK2m, Inc.201412—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K140066Infill CervicalPinnacle Spine Group, LLC20140—
+3K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133321Alamo CAlliance Partners, LLC20143—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K131671MectalifMedacta International201322—
+3K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+3K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+3K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K111726Pathway AvidCustom Spine, Inc.201295—
+3K112862Mecta-CMedacta International201114—
+3K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K111774Pathway Model 07XXXXCustom Spine201115—
+3K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K110927MectalifMedacta International2011301
+3K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+3K103169AleuttianK2m, Inc.2011572—
+3K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K101923Concorde Curve SystemDepuy Spine2010609—
+3K093093Small Plateau Spacer SystemLife Spine2010393—
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K101302Aleutian Ibf SystemK2m, Inc.2010595—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+3K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+3K072326Ostapek VBR SystemCo-Ligne AG20081—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—