510(k) Report

Devices descending from K060979

710 later devices reach Xia Titanium and 4.5 Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+1K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+1K092605Xia 4.5 Spinal SystemStryker Spine200998—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+1K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+1K072605Malibu Spinal SystemSeaspine, Inc.200767—
+1K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+1K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+1K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+2K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+2K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+2K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+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—
+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—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K101144Modification to:Radius Spinal SystemStryker Spine201090—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+2K083393Xia 3 Spinal SystemStryker Spine20092921
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+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—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+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—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—