510(k) Report

Devices descending from K060361

734 later devices reach Xia Spinal System, Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+1K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+1K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+1K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+1K092605Xia 4.5 Spinal SystemStryker Spine200998—
+1K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+1K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+1K073151Mantis Spinal SystemStryker Corp.2007111—
+1K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+1K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+1K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+1K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+2K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+2K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+2K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+2K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K083393Xia 3 Spinal SystemStryker Spine20092921
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233300POWEReam 1/4 DriveStryker Instruments20231—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—