510(k) Report

Devices descending from K943586

346 later devices reach Zirconia Ceramic Modular Heads (Astro Met) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042091Biolox Delta Ceramic HeadsBiomet, Inc.20053452
+2K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+2K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+2K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+2K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+2K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+2K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+2K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+3K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+3K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+3K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+3K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+3K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+3K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+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—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+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—
+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—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+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—
+4K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+4K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+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—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—