510(k) Report

Devices descending from K961379

4 later devices reach Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc.19993—
+2K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+2K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc.20010—
+3K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—