510(k) Report

Devices descending from K052761

735 later devices reach Modification to: 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—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K103292Trio Trauma Spinal SystemStryker Corporation201185—
+1K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+1K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+2K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+2K073151Mantis Spinal SystemStryker Corp.2007111—
+2K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+2K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+2K061813Mantis Spinal SystemStryker Spine20061352
+2K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K092631Mantis Redux Spinal SystemStryker Spine2009110—
+3K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+3K083393Xia 3 Spinal SystemStryker Spine20092921
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+3K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—