510(k) Report

Devices descending from K840643

310 later devices reach Harris-Galante Porous Total Hip Sys through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+5K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+5K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+5K093472Trinity Acetabular SystemCorin USA20101171
+5K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+5K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+5K081023Evolis Total Knee SystemMedacta International S.A.2008781
+5K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+5K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+6K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+6K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+6K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+6K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K142761Corin TaperFit Hip StemCorin USA201541
+6K142069GMK ExtensionMedacta International20144—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+6K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+6K131647Trinity Acetabular SystemCorin USA201322—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K131310GMK Full PE Tibial ComponentsMedacta International20132—
+6K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+6K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+6K130128Trinity Acetabular SystemCorin Medical201317—
+6K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+6K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+6K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+6K121563Corin Trifit TS HipCorin USA2012101
+6K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+6K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+6K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+6K121416GMK SphereMedacta International201220—
+6K120790GMK - Line ExtensionMedacta International201211—
+6K113571GMK Resufacing Patella Size 4Medacta International201223—
+6K111283GMK Revision Hybrid LinersMedacta International20110—
+6K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+6K090988GMK Total Knee SystemMedacta International S.A.2009521
+6K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+7K262057GMK ExtensionMedacta International SA20260—
+7K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+7K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+7K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+7K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+7K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+7K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+7K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+7K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+7K211664GMK Sphere RevisionMedacta International S.A.20210—
+7K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+7K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—