510(k) Report

Devices descending from K141953

265 later devices reach Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+1K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+1K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+1K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+1K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+1K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+1K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+1K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+2K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+2K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K183407Triton CageMedyssey USA, Inc.20190—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+2K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+2K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+2K161129Pillar SA PTCOrthofix, Inc.201619—
+2K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+3K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+3K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—