510(k) K243574

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique by Microport Orthopedics, Inc. — Product Code JWH

K243574 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique". The FDA issued a decision of Substantially Equivalent on February 18, 2025. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.