510(k) Report

Devices descending from K160515

2 later devices reach PS2 Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+2K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—