510(k) Report

Devices descending from K902365

185 later devices reach Modular Unipolar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+6K123392Avenir Muller StemZimmer GmbH2013414
+6K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K203041SMS Cementless StemMedacta International S.A.20201—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+7K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+7K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+7K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+7K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+7K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+7K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+7K163577Ecofit® Hip SystemImplantcast GmbH201791
+7K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+7K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+7K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+7K141327Minima S SystemLima Corporate S.P.A.20145—
+7K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+7K131884Avenir Cemented Hip StemZimmer GmbH20131—
+7K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+7K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+7K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+8K252451EPORE® XO cup systemImplantcast GmbH20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+8K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+8K233476Z1 Hip SystemOrchard Medical Development202421
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+8K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K203420EcoFit® Hip SystemImplantcast GmbH20214—
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+8K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+8K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+8K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+8K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+8K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+8K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+8K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+8K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+8K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+8K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+8K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+9K260831Z1 Hip SystemZimmer, Inc.20260—
+9K251906Z1 Hip SystemZimmer, Inc.20251—
+9K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+9K192126AMIStem-P Short NeckMedacta International S.A.20191—
+9K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+9K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+9K181254Quadra PMedacta International S.A.20187—
+9K170473C2 femoral stemLima Corporate S.P.A.20170—
+9K160011H-Max S stemLima Corporate S.P.A.20161—
+10K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+10K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+10K202730Quadra-PMedacta International S.A.20201—
+10K192827Quadra-PMedacta International S.A.20206—
+11K220405Amis K LongMedacta International S.A.20220—
+11K210062Mectaplug PE IIMedacta International S.A.20210—