510(k) Report

Devices descending from K133813

137 later devices reach Flxfit Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+1K171519FLXfit™Expanding Orthopedics, Inc.2017711
+1K153400ProLift Expandable SystemLife Spine, Inc.201672—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181397DualXInnovasive, Inc.201815—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K261430TruLift Expandable SystemLife Spine, Inc.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—