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
+7K210062Mectaplug PE IIMedacta International S.A.20210—
+7K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+7K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+7K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+7K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+7K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+7K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+7K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+7K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K162035GMK SphereMedacta International S.A.201710—
+7K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+7K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+7K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+7K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+7K140826GMK Sphere ExtensionMedacta International201417—
+7K133630GMK Short StemMedacta International20131—
+7K131952Corin Metafix Hip StemCorin USA20134—
+7K123721GMK Revision ExtensionMedacta International20133—
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K122232GMK NarrowMedacta International20128—
+7K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+7K111911Corin Optimom Modular HeadCorin USA201162—
+7K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+7K103721Mpact Acetabular SystemMedacta International201121—
+7K103352Versafitcup CC TrioMedacta International20114—
+7K102437GMK Revision Knee SystemMedacta International S.A.201034—
+7K093806Myknee Cutting BlocksMedacta International S.A.201016—
+8K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+8K241461Mpact Constrained LinerMedacta International S.A.20251—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+8K230011Mpact ExtensionMedacta International S.A.20233—
+8K231037MyKnee UNI-STMedacta International S.A.20230—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+8K211866Bencox THR SystemCorentec Co., Ltd.20210—
+8K200391MPACT ExtensionMedacta International S.A.20210—
+8K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+8K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K193559NextAR TKA PlatformMedacta Inernational SA202012—
+8K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K191831MobiliT CupCorin U.S.A. Limited20203—
+8K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+8K183582MPACT ExtensionMedacta International S.A.20194—
+8K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+8K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+8K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+8K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+8K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+8K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K143453Mpact Double Mobility SystemMedacta International20151—
+8K132879Mpact ExtensionMedacta International201411—
+8K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+8K131458Mpact DM Liner ConverterMedacta International20133—
+8K123692Pipeline Knee SystemPipeline Orthopedics20130—
+8K122911Versafitcup CC Trio ExtensionMedacta International20121—
+8K122641Mpact ExtensionMedacta International201214—
+8K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+8K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+8K111145Endo HeadMedacta International20110—
+9K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+9K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+9K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+9K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K211891DM Converter - TiN coatedMedacta International S.A.20220—
+9K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+9K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+9K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K202152NextAR TKA PlatformMedacta International S.A.202011—
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—