510(k) Report

Devices descending from K141942

459 later devices reach Midline II TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+1K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+1K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+1K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K181818Scarlet AL-TSpineart201864—
+2K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K161129Pillar SA PTCOrthofix, Inc.201619—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K192993Scarlet AL-TSpineart20201—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—