510(k) Report

Devices descending from K062995

26 later devices reach M2A-Magnum Tri-Spike Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+1K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+1K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K261576Icona Hip StemCorin, Ltd.20260—