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
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K192993Scarlet AL-TSpineart20201—
+6K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K193174Keos Lumbar IBFDKeos20190—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+6K183259Idys™ TLIF TiVacClariance, Sas20191—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181818Scarlet AL-TSpineart201864—
+6K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+6K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181203Juliet TiSpineart20181—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K173702Juliet Ti LLSpineart20182—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K171140Matrixx SystemNexxt Spine, LLC2017145—