510(k) Report

Devices descending from K041119

640 later devices reach Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+2K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+2K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+2K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+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—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—