510(k) Report

Devices descending from K974807

151 later devices reach Osteo Austin Moore Endoprosthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031841Spacer G Temporary Hip ProsthesisExactech, Inc.200432—
+1K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999117—
+2K252326InterSpace GV Hip SpacerTecres S.P.A.20250—
+2K192041G21 SpaceFlex HipG21, S.R.L.20190—
+2K080979Stageone Select Cement Spacer Molds for Temporary Hip ReplacementBiomet Manufacturing Corp2008315
+2K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A.200820—
+2K052990Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…Biomet, Inc.2005305
+2K042037M2A Magnum SystemBiomet, Inc.2004116—
+3K161166StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc.2016215
+3K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+3K101356Spacer-G and Spacer-KTecres S.P.A.201119—
+3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+3K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+3K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp200626—
+3K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+3K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH20067413
+4K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH20191—
+4K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC201216—
+4K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+4K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K220492COPAL exchange G hip spacerHeraeus Medical GmbH20220—
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K201673SMS Cementless StemMedacta International S.A.20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K192236Fitmore Hip StemZimmer GmbH20191—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC20195—
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K190216SpaceFlex KneeG21, S.R.L.20191—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K181693SMS Femoral StemMedacta International S.A.20184—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173967Remedy Acetabular CupOsteoremedies, LLC20185—
+5K170072Fitmore® Hip StemZimmer GmbH20170—
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K123392Avenir Muller StemZimmer GmbH2013414
+5K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+6K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+6K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC20240—
+6K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC20231—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K203041SMS Cementless StemMedacta International S.A.20201—
+6K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+6K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+6K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+6K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+6K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+6K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+6K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+6K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+6K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—