510(k) Report

Devices descending from K053505

19 later devices reach Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+1K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+1K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+2K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+2K1701493DMetal Tibial ConesMedacta International S.A.20170—
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+2K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K153437Apex Revision Knee SystemOmnilife Science201541
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K163332Apex Revision Knee SystemOmnilife Science20173—
+6K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+7K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+7K201611Apex Knee SystemOmnilife Science20210—