510(k) Report

Devices descending from K964769

363 later devices reach Versys Hip System--Fiber Metal Taper Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+1K051491Trabecular Metal Primary Hip ProsthesisZimmer, Inc.200525
+1K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.2003843
+1K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc.20032962
+1K984492Tigran Hip ProsthesisPonmed, Ltd.19990—
+1K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc.19980—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+2K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+2K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20160—
+2K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+2K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+2K083312Minihip StemCorin USA201015—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+2K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+2K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+2K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+2K061461Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Zimmer, Inc.20065—
+2K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+2K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.200411—
+2K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K201673SMS Cementless StemMedacta International S.A.20203—
+3K192236Fitmore Hip StemZimmer GmbH20191—
+3K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—
+3K181693SMS Femoral StemMedacta International S.A.20184—
+3K170072Fitmore® Hip StemZimmer GmbH20170—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+3K131986Corin Minihip StemCorin USA20133—
+3K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+3K123392Avenir Muller StemZimmer GmbH2013414
+3K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+3K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+3K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH201101
+3K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+3K103518Trinity Acetabular SystemCorin USA20118—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+3K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+3K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+3K042344Excia Total Hip SystemAesculap, Inc.200519810
+3K043079Bicontact Hip System with U-CapAesculap2004166—
+4K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203041SMS Cementless StemMedacta International S.A.20201—
+4K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+4K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+4K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+4K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+4K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+4K162775Legion Cone SystemSmith & Nephew, Inc.201752
+4K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+4K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+4K131884Avenir Cemented Hip StemZimmer GmbH20131—