510(k) Report

Devices descending from K111492

314 later devices reach Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+1K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+1K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+1K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+1K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+1K113666Xia 3 Spinal SystemStryker Spine2012251—
+1K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+2K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+2K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+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—
+2K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131129Cas Psi ShoulderZimmer Cas201339—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+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—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173445Materialise TKA Guide SystemMaterialise NV201891
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170647Connector SystemOrthofix, Inc.201718—
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—