510(k) Report

Devices descending from K060979

710 later devices reach Xia Titanium and 4.5 Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K173508Everest Spinal SystemK2m20189—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133103Aversion Pedicle Screw SystemK7, LLC20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+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—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K113044Synthes MirsSynthes Spine2011933
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+3K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—