510(k) Report

Devices descending from K943230

318 later devices reach Mayo Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+5K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+5K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K142069GMK ExtensionMedacta International20144—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+5K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+5K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+5K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+5K121416GMK SphereMedacta International201220—
+5K120790GMK - Line ExtensionMedacta International201211—
+5K113571GMK Resufacing Patella Size 4Medacta International201223—
+5K111283GMK Revision Hybrid LinersMedacta International20110—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K262057GMK ExtensionMedacta International SA20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—