510(k) Report

Devices descending from K031635

1,201 later devices reach Depuy Acromed VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K173893TrabisColigne AG20180—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172065Scarlet AC-TSpineart20172—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K153621Juliet® TiSpineart2016751
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—