510(k) Report

Devices descending from K011110

228 later devices reach M2A Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K201673SMS Cementless StemMedacta International S.A.20203—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K192236Fitmore Hip StemZimmer GmbH20191—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K170072Fitmore® Hip StemZimmer GmbH20170—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+5K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—