510(k) Report

Devices descending from K042673

235 later devices reach Zodiac Polyaxial Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+1K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+1K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+1K110321Tiger Spine SystemCorelink, LLC201183—
+1K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108—
+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—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K201568Calvary Spine Pedicle Screw SystemCalvary Spine, LLC20200—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+2K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+2K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+2K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+2K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+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
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+2K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+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—
+3K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+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—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.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—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352