510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+1K032812Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc.20035651
+1K031302Sustain SpacerGlobus Medical, Inc.2003911—
+1K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)20031,683—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+2K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+2K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564—
+2K050850Xpand Corpectomy SpacerGlobus Medical, Inc.2005284—
+2K040482Ebi Esl Spine Spacer SystemEbi, L.P.20041,621—
+2K040284Sustain Radiolucent SpacerGlobus Medical, Inc.2004906—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+3K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+3K072465Niko Corpectomy SpacerGlobus Medical, Inc.2007327—
+3K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656—
+3K061380Retain Radiolucent SpacerGlobus Medical, Inc.20060—
+3K060916Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC20061—
+3K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc.2006274—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+3K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+3K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+3K042268Ebi Cas Spine Spacer SystemEbi, L.P.20041,620—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+4K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—