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
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+3K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K142030STGC-LordoticCardinal Spine, LLC201558—
+3K142328nvcNvision Biomedical Technologies, LLC20144—
+3K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+3K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+3K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+3K141337Arena-CSpinefrontier, Inc.20141—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+3K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+3K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K121178Transcorp Acif SystemTranscorp, Inc.20130—
+3K131372Mobis IISignus Medizintechnik GmbH2013462—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+3K123969XiphosDifusion Technologies201314—
+3K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+3K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+3K120401Alamo TAlliance Partners, LLC20121—
+3K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+3K121176STGCCardinal Spine, LLC201259—
+3K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+3K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+3K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+3K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+3K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+3K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+3K120576Zavation Ibf SystemZavation, LLC201232—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+3K113138Aleutian SystemK2m, Inc.2012549—
+3K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K112862Mecta-CMedacta International201114—
+3K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+3K111484DiscoveryIntuitive Spine, LLC20111—
+3K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+3K110177Helena SystemRoyal Oak Medical Devices20110—
+3K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K103111Forza Spacer SystemOrthofix, Inc.20113431
+3K100698STCCCardinal Spine, LLC2011346—
+3K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+3K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+3K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+3K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+3K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+3K073502Vertebron VBR SystemVertebron, Inc.200812—
+4K261049Scala® TLSpineart SA20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—