510(k) Report

Devices descending from K042714

838 later devices reach Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200312Tryptik TiSpineart20202—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K1803473d CageFims Co., Ltd.20190—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181818Scarlet AL-TSpineart201864—
+7K181397DualXInnovasive, Inc.201815—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171425Concorde LiftMedos International SARL201782