510(k) Report

Devices descending from K003478

247 later devices reach Triology Acetabular System 46MM Large Head Liners, Model 6310 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc.20092463
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K151448Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsZimmer, Inc.20156—
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+2K123019Longevity IT Highly Crosslinked Polyethyene LinersZimmer, Inc.20120—
+2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+2K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+2K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc.2011137—
+2K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc.2010143—
+2K101730Longevity IT Highly Crosslinked Polyethylene Constrained LinersZimmer, Inc.20102—
+2K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc.2010144—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K182099Delta TT ProLima Corporate S.P.A.20183—
+3K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+3K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+3K130128Trinity Acetabular SystemCorin Medical201317—
+3K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+3K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+3K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+3K111911Corin Optimom Modular HeadCorin USA201162—
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—