510(k) Report

Devices descending from K031803

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+4K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+4K132158Novohip Total Hip SystemNovosource, Inc.201461
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K131986Corin Minihip StemCorin USA20133—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+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—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+4K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+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—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+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—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K161592Persona Partial Knee SystemBiomet, Inc.201652
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+5K142761Corin TaperFit Hip StemCorin USA201541