510(k) Report

Devices descending from K033090

180 later devices reach Icon Polyaxial Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+1K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+1K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+1K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+1K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+1K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+1K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+1K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+2K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+2K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+2K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+2K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371