510(k) Report

Devices descending from K040644

222 later devices reach Modification to Depuy Ceramic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131986Corin Minihip StemCorin USA20133—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+6K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+7K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K121563Corin Trifit TS HipCorin USA2012101
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K171249Entrada™ hip stemOrtho Development Corporation20172—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—