510(k) Report

Devices descending from K100089

797 later devices reach Synthes T-Pal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+1K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+1K191353COMET Lumbar Interbody Fusion CageBaui Biotech Co., Ltd.20200—
+1K181231DePuy Synthes T-PAL Spacer SystemDepuy Synthes Spine20180—
+1K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+1K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+1K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+1K153400ProLift Expandable SystemLife Spine, Inc.201672—
+1K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical201633—
+1K151276DePuy Synthes T-PAL Ti SpacerSynthes USA Products, LLC2015129—
+1K141798Sypher Spacer SystemBiogennix, LLC20151—
+1K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+1K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+1K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K112664Zavation Ibf SystemsZavation, LLC201137—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+2K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K1803473d CageFims Co., Ltd.20190—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K181337Sypher Spacer SystemBiogennix, LLC20180—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171519FLXfit™Expanding Orthopedics, Inc.2017711
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133967Interbody Cage SystemAurora Spine2014227—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K122021Sterispine LC CageSafe Orthopaedics20122—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+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—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—