510(k) Report

Devices descending from K043473

289 later devices reach Modification to Xia Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+1K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+1K092631Mantis Redux Spinal SystemStryker Spine2009110—
+1K073151Mantis Spinal SystemStryker Corp.2007111—
+1K071945S4 Spinal SystemAesculap Implant Systems200795—
+1K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+1K062698Trio + Spinal SystemStryker Spine2006882
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K052181Modification to Xia Spinal SystemStryker Spine2005202—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K101144Modification to:Radius Spinal SystemStryker Spine201090—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+2K090657Modification to: S4 Spinal SystemAesculap Implant Systems200994—
+2K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+2K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162367Erisma® LP MISClariance, Sas20162—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—