510(k) Report

Devices descending from K093533

404 later devices reach Zimmer Patient Specific Instruments System, Version 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+1K111492Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsMaterialise NV20113142
+1K103136Surgicase CMF, Surgicase Connect, Surgicase GuideMaterialise NV2011901
+1K102795Signature Planner; Signature GuidesMaterialise NV2011994
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K172650Materialise PKA Guide SystemMaterialise NV20176—
+2K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+2K140257Signature Planner, Signature GuidesMaterialise NV20140—
+2K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K120956VSP SystemMedical Modeling, Inc.201228—
+2K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K112389Surgicase Connect, Surgicase GuideMaterialise NV201259—
+2K111863Signature Planner,Signature GuidesMaterialise NV201271—
+2K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+2K111558Surgicase GuideMaterialise NV20120—
+2K110415Signature Planner / Signature GuidesMaterialise NV2011131
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K212570OsteoPlan SystemOsteomed, LLC20221—
+3K192282MedCAD® AccuPlan® SystemMedcad20203—
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+3K173970Materialise PKA Guide SystemMaterialise NV20185—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173445Materialise TKA Guide SystemMaterialise NV201891
+3K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K162273Materialise TKA Guide SystemMaterialise NV201611—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+3K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+3K133907VSP SystemMedical Modeling, Inc.201481
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K223427Mimics Enlight CMFMaterialise NV20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231520tmCMF SolutionTechmah Cmf20231—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K223024MedCAD AccuPlan SystemMedcad20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K221337Materialise TKA Guide SystemMaterialise NV202221
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+4K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K193499DigiGuide SystemProtomed, Inc.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202207Materialise PKA Guide SystemMaterialise NV20200—
+4K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—