510(k) Report

Devices descending from K953443

9 later devices reach Consensus PCL Subsituting Tibial Insert through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+1K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+1K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+2K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+3K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+3K201611Apex Knee SystemOmnilife Science20210—
+3K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+4K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—