510(k) Report

Devices descending from K022902

285 later devices reach Smith & Nephew Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K262057GMK ExtensionMedacta International SA20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K162035GMK SphereMedacta International S.A.201710—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133630GMK Short StemMedacta International20131—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K123721GMK Revision ExtensionMedacta International20133—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K122232GMK NarrowMedacta International20128—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102437GMK Revision Knee SystemMedacta International S.A.201034—
+5K093806Myknee Cutting BlocksMedacta International S.A.201016—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K183582MPACT ExtensionMedacta International S.A.20194—