510(k) Report

Devices descending from K031183

14 later devices reach Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K094017Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.201076
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K153437Apex Revision Knee SystemOmnilife Science201541
+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—