510(k) Report

Devices descending from K053536

74 later devices reach Durom Acetabular Component and Metasul LDH Large Diameter Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+2K201673SMS Cementless StemMedacta International S.A.20203—
+2K192236Fitmore Hip StemZimmer GmbH20191—
+2K181693SMS Femoral StemMedacta International S.A.20184—
+2K170072Fitmore® Hip StemZimmer GmbH20170—
+2K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+2K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+2K123392Avenir Muller StemZimmer GmbH2013414
+2K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+3K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K203041SMS Cementless StemMedacta International S.A.20201—
+3K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+3K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+3K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+3K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+3K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+3K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+3K131884Avenir Cemented Hip StemZimmer GmbH20131—
+3K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+4K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K233476Z1 Hip SystemOrchard Medical Development202421
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+4K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+4K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K260831Z1 Hip SystemZimmer, Inc.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K251906Z1 Hip SystemZimmer, Inc.20251—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K192126AMIStem-P Short NeckMedacta International S.A.20191—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K181254Quadra PMedacta International S.A.20187—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K202730Quadra-PMedacta International S.A.20201—
+6K192827Quadra-PMedacta International S.A.20206—
+7K220405Amis K LongMedacta International S.A.20220—
+7K210062Mectaplug PE IIMedacta International S.A.20210—