510(k) Report

Devices descending from K031585

579 later devices reach U&I, Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+2K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd.20112—
+2K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+2K100765Fixpine II SystemDio Medical Co., Ltd.201023—
+2K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+2K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+2K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+2K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+2K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+2K092128Modification to: PSS SystemSpinal USA200936—
+2K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+2K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+2K090033Modification to: PSS SystemSpinal USA200937—
+2K082509Eos Spinal SystemKorea Bone Bank Co., Ltd.2008140—
+2K0824534CIS Solar and Apollon Spine SystemsSolco Biomedical Co., Ltd.2008126—
+2K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+2K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+2K081296Preference Pedicle Screw SystemUs Spine20083—
+2K080876DVX Spine SystemBk Meditech, Co., Ltd.20081—
+2K080767Conquest Spinal SystemLife Spine200821—
+2K073240PSS SystemSpinal USA200836—
+2K062912Scient'x Spinal SystemScient'X200736—
+2K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+3K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+3K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—