510(k) Report

Devices descending from K072991

647 later devices reach Patriot Spacers: Colonial Acdf through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+1K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+1K160125Cascadia Interbody SystemK2m2016315—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+1K083389Coalition SpacerGlobus Medical, Inc.2009633—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K250560BEE HANGMedical GmbH20250—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+2K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+2K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203444BEE HA CageNGMedical GmbH20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K171312FortiCore®Nanovis, LLC20183—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K151939COALITION SpacersGlobus Medical, Inc.2016152—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K131449Coalition SpacerGlobus Medical, Inc.2013235—
+2K122771Spinal Elements Cervical Intervertebral Body Fusion SystemSpinal Elements, Inc.2013147—
+2K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+2K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K112388Lanx Cervical SALanx, Inc.201126—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+2K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—