510(k) Report

Devices descending from K994415

194 later devices reach Marathon Cross-Linked Polyethylene Acetabular Cup Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+1K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+1K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+1K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+1K062489Apex Hcla Acetabular Cup LinersOmnilife Science200763—
+1K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.200738—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+2K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K131647Trinity Acetabular SystemCorin USA201322—
+2K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+2K130128Trinity Acetabular SystemCorin Medical201317—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+2K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+2K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+2K111911Corin Optimom Modular HeadCorin USA201162—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103352Versafitcup CC TrioMedacta International20114—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+2K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+2K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+2K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+2K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+2K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.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—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K132879Mpact ExtensionMedacta International201411—
+3K131952Corin Metafix Hip StemCorin USA20134—
+3K131986Corin Minihip StemCorin USA20133—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—