510(k) Report

Devices descending from K991106

3 later devices reach P.F.C. Sigma Porous Modular Keel Tibial Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+1K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc.20010—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—