510(k) Report

Devices descending from K103120

110 later devices reach Corin Biolox Delta Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+1K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+1K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+1K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+2K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+2K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+2K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+2K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K131952Corin Metafix Hip StemCorin USA20134—
+2K131986Corin Minihip StemCorin USA20133—
+2K131647Trinity Acetabular SystemCorin USA201322—
+2K130128Trinity Acetabular SystemCorin Medical201317—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+2K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+2K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+2K111911Corin Optimom Modular HeadCorin USA201162—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K191831MobiliT CupCorin U.S.A. Limited20203—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+3K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K130634Corin Metafix Hip StemCorin USA20135—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211