510(k) Report

Devices descending from K020279

693 later devices reach Forex Corporation, Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+3K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+3K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+4K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited20240—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K141397Sure-Lok C Extended Tab Pedicle Screw SystemPrecision Spine, Inc.20140—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—