510(k) Report

Devices descending from K002858

749 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+1K073151Mantis Spinal SystemStryker Corp.2007111—
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+1K050461Xia 4.5 Spinal SystemStryker Spine2005742—
+1K043473Modification to Xia Spinal SystemStryker Spine2005289—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+2K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.20160—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K071945S4 Spinal SystemAesculap Implant Systems200795—
+2K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+2K062698Trio + Spinal SystemStryker Spine2006882
+2K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+2K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005735—
+2K052181Modification to Xia Spinal SystemStryker Spine2005202—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162367Erisma® LP MISClariance, Sas20162—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K101144Modification to:Radius Spinal SystemStryker Spine201090—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+3K090657Modification to: S4 Spinal SystemAesculap Implant Systems200994—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+3K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—