510(k) Report

Devices descending from K062748

219 later devices reach Modification: to Depuy Delta Ceramic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+1K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+1K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+2K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+2K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+2K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+2K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+2K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+2K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+3K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K132158Novohip Total Hip SystemNovosource, Inc.201461
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+3K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—