510(k) Report

Devices descending from K113527

103 later devices reach Opticage Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234150Lucent® XPSpinal Elements20240—
+1K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+1K171425Concorde LiftMedos International SARL201782
+1K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+1K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+1K153400ProLift Expandable SystemLife Spine, Inc.201672—
+1K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+1K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K182349Concorde LiftMedos International SARL20190—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K173537Concorde Lift™Medos International SARL20181—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+2K133207Staxx (R) SystemSpine Wave, Inc.20131—
+2K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+3K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+3K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+3K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+4K261430TruLift Expandable SystemLife Spine, Inc.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—