510(k) Report

Devices descending from K071535

217 later devices reach Biolox Delta Ceramic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+1K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+1K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+1K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+1K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+1K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+1K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+1K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+1K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+1K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+1K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+1K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+1K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+2K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+2K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+2K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+2K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K132158Novohip Total Hip SystemNovosource, Inc.201461
+2K131518Mectacer Biolox Option HeadsMedacta International20130—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+2K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+2K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+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—
+3K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+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—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—