510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+5K132574Pass LP Spinal SystemMedicrea International20130—