510(k) Report

Devices descending from K152475

236 later devices reach FORZA PTC Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+1K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+1K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+1K183407Triton CageMedyssey USA, Inc.20190—
+1K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+1K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+1K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+1K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+1K161129Pillar SA PTCOrthofix, Inc.201619—
+1K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+2K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+2K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+2K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+2K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+2K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+2K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+2K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+3K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+3K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+3K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+3K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—