510(k) Report

Devices descending from K122382

5 later devices reach Dynasty Biofoam Shell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+1K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+1K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION®…Microport Orthopedics, Inc.20172—
+2K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—