510(k) Report

Devices descending from K082358

428 later devices reach Smith & Nephew, Inc. Patient Matched Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172336Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc.20186—
+1K130708Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc.20138—
+1K110533Stryker Patient Specific Cutting GuideStryker Corp.20113Class I
+1K110415Signature Planner / Signature GuidesMaterialise NV2011131
+1K103136Surgicase CMF, Surgicase Connect, Surgicase GuideMaterialise NV2011901
+1K093806Myknee Cutting BlocksMedacta International S.A.201016—
+1K093533Zimmer Patient Specific Instruments System, Version 2.0Materialise NV2010404—
+1K091263Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model…Materialise NV20090—
+2K231037MyKnee UNI-STMedacta International S.A.20230—
+2K193559NextAR TKA PlatformMedacta Inernational SA202012—
+2K183010Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc.20185—
+2K173970Materialise PKA Guide SystemMaterialise NV20185—
+2K173445Materialise TKA Guide SystemMaterialise NV201891
+2K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+2K170282Smith & Nephew VISIONAIRE Adaptive GuidesSmith & Nephew, Inc.20177—
+2K140257Signature Planner, Signature GuidesMaterialise NV20140—
+2K120956VSP SystemMedical Modeling, Inc.201228—
+2K122053Shapematch Cutting GuideStryker Corp.20122Class I
+2K112389Surgicase Connect, Surgicase GuideMaterialise NV201259—
+2K111558Surgicase GuideMaterialise NV20120—
+2K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+2K111492Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsMaterialise NV20113142
+2K102795Signature Planner; Signature GuidesMaterialise NV2011994
+3K252847NextAR Hip PlatformMedacta International S.A.20260—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K221337Materialise TKA Guide SystemMaterialise NV202221
+3K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+3K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+3K212570OsteoPlan SystemOsteomed, LLC20221—
+3K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+3K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+3K210153NextAR RSA PlatformMedacta International S.A.202151
+3K192282MedCAD® AccuPlan® SystemMedcad20203—
+3K202152NextAR TKA PlatformMedacta International S.A.202011—
+3K202207Materialise PKA Guide SystemMaterialise NV20200—
+3K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+3K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+3K200826Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc.20204—
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K172650Materialise PKA Guide SystemMaterialise NV20176—
+3K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+3K133907VSP SystemMedical Modeling, Inc.201481
+3K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K111863Signature Planner,Signature GuidesMaterialise NV201271—
+3K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250477NextAR (TM) SpineMedacta International S.A.20250—
+4K251554Materialise TKA Guide SystemMaterialise NV20251—
+4K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K223427Mimics Enlight CMFMaterialise NV20240—
+4K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+4K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+4K231520tmCMF SolutionTechmah Cmf20231—
+4K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+4K223024MedCAD AccuPlan SystemMedcad20230—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+4K193499DigiGuide SystemProtomed, Inc.20200—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192192VSP System3D Systems20203—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20191—
+4K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20197—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K170419SurgiCase ViewerMaterialise NV20173—
+4K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV20178—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K162273Materialise TKA Guide SystemMaterialise NV201611—
+4K151285VSP Cranial System3D Systems, Inc.20160—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—