510(k) Report

Devices descending from K023102

306 later devices reach Accolade TMZF Plus HA 127 Size 0 Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+4K192352MiniMAXMedacta International S.A.20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K142069GMK ExtensionMedacta International20144—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131986Corin Minihip StemCorin USA20133—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+4K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K111911Corin Optimom Modular HeadCorin USA201162—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K262057GMK ExtensionMedacta International SA20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+5K201673SMS Cementless StemMedacta International S.A.20203—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K162035GMK SphereMedacta International S.A.201710—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133630GMK Short StemMedacta International20131—
+5K123721GMK Revision ExtensionMedacta International20133—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—