510(k) Report

Devices descending from K043206

1,571 later devices reach Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K153621Juliet® TiSpineart2016751
+5K160631Keos Lumbar IBFDKeos20161—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+5K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+5K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K140348Interbody CageEisertech, LLC2015235—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K141187Impix Alif S/aMedicrea International SA201501
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K142277Juliet POSpineart2014119—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K133200Stalif C (R)Centinel Spine, Inc.201410—
+5K140474Juliet OLSpineart2014120—
+5K132738Cogent Med-LifCogent Spine, LLC201413—
+5K132596Proposed OptimusCustom Spine, Inc.201451
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—