510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+3K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173508Everest Spinal SystemK2m20189—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171321K2M Navigation InstrumentsK2m201711
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, 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—
+3K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—