510(k) Report

Devices descending from K061312

343 later devices reach 36MM Biolox Delta Ceramic Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+1K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+1K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+1K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+1K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+1K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+2K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+2K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+2K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+2K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+2K131518Mectacer Biolox Option HeadsMedacta International20130—
+2K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+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—
+2K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+2K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+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—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+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—
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+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—
+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—
+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—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+3K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+3K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+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—
+3K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—