510(k) Report

Devices descending from K042051

355 later devices reach Arcomxl Polyethylene Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+4K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+4K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+4K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+4K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+4K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+5K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K181947Persona Revision Knee SystemZimmer, Inc.201841
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K161592Persona Partial Knee SystemBiomet, Inc.201652
+5K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+5K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+5K132158Novohip Total Hip SystemNovosource, Inc.201461
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+6K261453G7® Acetabular SystemZimmer Biomet20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251834Persona Partial KneeZimmer Biomet20250—
+6K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—