510(k) Report

Devices descending from K011533

378 later devices reach Depuy Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+5K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+5K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+5K132158Novohip Total Hip SystemNovosource, Inc.201461
+5K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+5K131986Corin Minihip StemCorin USA20133—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+5K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+5K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+5K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+5K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+5K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+6K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+6K243444Bioceram Azul® HeadKyocera Corporation20240—
+6K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+6K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+6K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+6K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+6K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+6K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+6K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+6K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+6K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+6K190057DJO Acetabular SystemEncore Medical L.P.201925
+6K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+6K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+6K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K181947Persona Revision Knee SystemZimmer, Inc.201841
+6K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+6K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+6K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+6K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+6K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+6K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+6K161592Persona Partial Knee SystemBiomet, Inc.201652
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—