510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K102636Zenith Pedicle SystemApollo Spine, Inc.20110—
+1K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+1K092631Mantis Redux Spinal SystemStryker Spine2009110—
+1K083393Xia 3 Spinal SystemStryker Spine20092921
+1K081165Ellipse Lumbar Posterior Osteosynthesis SystemSpineart200819—
+1K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+1K073151Mantis Spinal SystemStryker Corp.2007111—
+1K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+1K062698Trio + Spinal SystemStryker Spine2006882
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+1K053115Xia Spinal SystemStryker Spine2005889—
+1K052971Stryker Spine Trio Spinal Fixation SystemStryker Spine20051122
+1K052181Modification to Xia Spinal SystemStryker Spine2005202—
+1K043180Stryker Spine Trio PSStryker Spine200588—
+1K043473Modification to Xia Spinal SystemStryker Spine2005289—
+2K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+2K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+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—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K151695Romeo posterior osteosynthesis systemSpineart201510—
+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—
+2K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart201411—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K140948Romeo Posterior Osteosynthesis SystemSpineart201410—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K130267Romeo Posterior Osteosynthesis SystemSpineart201312—
+2K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K112108Romeo Posterior Osteosynthesis SystemSpineart201113—
+2K111127Romeo Posterior Osteosynthesis SystemSpineart201113—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K101678Romeo Posterior Osteosynthesis SystemSpineart201016—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+2K093936Romeo Posterior Osteosynthesis SystemSpineart201010—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K093170Romeo Posterior Osteosynthesis SystemSpineart200918—
+2K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+2K071945S4 Spinal SystemAesculap Implant Systems200795—
+2K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+2K063601Pilot Spinal SystemLife Spine200724—
+2K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+2K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+2K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.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—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—