510(k) Report

Devices descending from K090566

639 later devices reach Pathway Avid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153400ProLift Expandable SystemLife Spine, Inc.201672—
+1K133717Longbow Spacer SystemLife Spine20149—
+1K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+1K132738Cogent Med-LifCogent Spine, LLC201413—
+1K132596Proposed OptimusCustom Spine, Inc.201451
+1K111726Pathway AvidCustom Spine, Inc.201295—
+1K112359Prow FusionNlt Spine, Ltd.2011601—
+2K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+2K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+2K190721LongBow TiLife Spine, Inc.20190—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K171519FLXfit™Expanding Orthopedics, Inc.2017711
+2K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+2K160291Optimus ALIF SystemAmendia, Inc.20160—
+2K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+2K130254Prow FusionNlt Spine, Ltd.20138—
+2K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+2K123913Latis SpacerGlobus Medical, Inc.201388—
+3K261430TruLift Expandable SystemLife Spine, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K181397DualXInnovasive, Inc.201815—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+3K151654Prow FusionNlt Spine, Ltd.20151—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+3K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+3K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K183064TxTi IBF SystemInnovasis, Inc.2019481
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—