510(k) Report

Devices descending from K052026

125 later devices reach Lineage a-Class Poly Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+1K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+1K142119Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc.20159—
+1K140043Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadMicroport Orthopedics, Inc.201410—
+1K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+1K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006106—
+2K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+2K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+2K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+2K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+2K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+2K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+2K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+2K103384Escalade Acetabular Cup SystemOrtho Development201131
+2K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+2K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+2K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+2K072963Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.200819—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+3K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K161080Escalade Legend Acetabular ShellOrtho Development Corporation20161—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+3K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+3K102423Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.2010172
+3K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+3K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+3K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242833Legend® Acetabular ShellOrtho Development Corp.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+4K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+4K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+4K132959Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.201413—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K103721Mpact Acetabular SystemMedacta International201121—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+5K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—