510(k) Report

Devices descending from K042271

16 later devices reach Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K131310GMK Full PE Tibial ComponentsMedacta International20132—
+1K122500Neo PS Knee SystemPipeline Orthopedics20131—
+1K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K262057GMK ExtensionMedacta International SA20260—
+2K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+2K213381Physica systemLima Corporate S.P.A.202101
+2K210062Mectaplug PE IIMedacta International S.A.20210—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—