510(k) Report

Devices descending from K042344

198 later devices reach Excia Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+1K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+1K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+1K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+1K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+1K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+1K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+1K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+1K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+1K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+1K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+1K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+1K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+1K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+1K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+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—
+2K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+2K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+2K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+2K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+2K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+2K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+2K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+2K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+2K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+2K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+2K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+2K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+2K083312Minihip StemCorin USA201015—
+2K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+2K081023Evolis Total Knee SystemMedacta International S.A.2008781
+2K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K142069GMK ExtensionMedacta International20144—
+3K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+3K131986Corin Minihip StemCorin USA20133—
+3K131310GMK Full PE Tibial ComponentsMedacta International20132—
+3K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+3K121416GMK SphereMedacta International201220—
+3K120790GMK - Line ExtensionMedacta International201211—
+3K113571GMK Resufacing Patella Size 4Medacta International201223—
+3K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+3K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+3K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+3K111283GMK Revision Hybrid LinersMedacta International20110—
+3K103518Trinity Acetabular SystemCorin USA20118—
+3K090988GMK Total Knee SystemMedacta International S.A.2009521
+3K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+4K262057GMK ExtensionMedacta International SA20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+4K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+4K162035GMK SphereMedacta International S.A.201710—
+4K140826GMK Sphere ExtensionMedacta International201417—
+4K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+4K133630GMK Short StemMedacta International20131—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K123721GMK Revision ExtensionMedacta International20133—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K122232GMK NarrowMedacta International20128—
+4K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+4K103721Mpact Acetabular SystemMedacta International201121—