510(k) Report

Devices descending from K123281

146 later devices reach Acculif TL-Peek Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+1K181397DualXInnovasive, Inc.201815—
+1K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+1K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+1K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+1K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+1K130194Acculif XL CageCoalign Innovations, Inc.20131—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+2K171519FLXfit™Expanding Orthopedics, Inc.2017711
+2K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+4K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+4K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K183064TxTi IBF SystemInnovasis, Inc.2019481
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—