510(k) Report

Devices descending from K103111

343 later devices reach Forza Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+1K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+1K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+1K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+1K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+1K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+2K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K183407Triton CageMedyssey USA, Inc.20190—
+2K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+2K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+2K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+2K161129Pillar SA PTCOrthofix, Inc.201619—
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K223326Axiom PSR SystemRestor3D202301
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K200429BEE CagesNGMedical GmbH202111—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+3K200312Tryptik TiSpineart20202—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K1803473d CageFims Co., Ltd.20190—
+3K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+4K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—