510(k) Report

Devices descending from K080361

13 later devices reach Regenerex Tibial Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+1K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K153437Apex Revision Knee SystemOmnilife Science201541
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K163332Apex Revision Knee SystemOmnilife Science20173—
+5K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+6K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+6K201611Apex Knee SystemOmnilife Science20210—