510(k) Report

Devices descending from K062148

106 later devices reach Depuy Pinnacle Altrx Acetabular Cup Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+1K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+1K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+1K103384Escalade Acetabular Cup SystemOrtho Development201131
+1K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+1K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+1K072963Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.200819—
+2K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+2K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+2K211866Bencox THR SystemCorentec Co., Ltd.20210—
+2K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+2K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K161080Escalade Legend Acetabular ShellOrtho Development Corporation20161—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K102423Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.2010172
+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—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242833Legend® Acetabular ShellOrtho Development Corp.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+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—
+3K132959Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.201413—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K103721Mpact Acetabular SystemMedacta International201121—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K221636EMPHASYS Acetabular SystemDepuy Ireland UC20227—
+4K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—