510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K171704CAPRI Corpectomy Cage SystemK2m201710—
+1K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+1K142030STGC-LordoticCardinal Spine, LLC201558—
+1K142016CAPRIK2m, Inc.201412—
+1K121176STGCCardinal Spine, LLC201259—
+1K111294Santorini Spinal SystemK2m, Inc.201218—
+1K093207Enduramesh, Model 762.XXXLucero Medical, LLC201011
+1K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+1K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+1K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+1K073649Bengal Stackable Cage SystemDepuy Spine, Inc.2008278—
+1K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+1K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+1K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+1K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+1K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+1K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC20050—
+1K041407Titanium Mesh ImplantInterpore Cross Intl.20040—
+1K032371Titanium Mesh SystemEncore Medical L.P.200426—
+1K030833Depuy Acromed VBR SystemDepuyacromed20031,224—
+1K022793Tetris Spinal ImplantSignus Medical, LLC20031,705—
+1K030249Surgical Titanium Mesh SystemDepuyacromed2003616—
+1K020522Modification to Surgical Titanium Mesh SystemDepuyacromed20021,234—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K190284Bengal Stackable Cage SystemMedos International SARL20190—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+2K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+2K172323Omnia Medical VBROmnia Medical, LLC20176—
+2K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K152568C-VBRCardinal Spine, LLC201657—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+2K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+2K122622EndurameshLucero Medical, LLC20120—
+2K122317Tetris IISignus Medizintechnik GmbH20122—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+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—
+2K080568X-Mesh Expandable Cage SystemDepuy Spine, Inc.2008615—
+2K080281PathwayCustom Spine, Inc.2008188—
+2K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+2K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+2K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+2K053508Synfix-LRSynthes Spine Co.Lp2006391
+2K051781Graftcage TLXOsteotech, Inc.20050Class I
+2K053080Graftcage AcxOsteotech, Inc.20050—
+2K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc.20050—
+2K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+2K041722Modification to VBR Spinal SystemDepuy Spine, Inc.20041,150—
+2K033663Spinal Concepts Inc. CodaSpinal Concepts, Inc.20041—
+2K032064Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc20041,2801
+2K031757Peek Tetris Spinal ImplantSignus Medical, LLC20031,702—
+2K031635Depuy Acromed VBR SystemDepuyacromed20031,201—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+3K173893TrabisColigne AG20180—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173148ACIFColigne AG20171—
+3K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K160631Keos Lumbar IBFDKeos20161—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+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—