510(k) K231947

EVOLUTION® Cement Keel by Microport Orthopedics, Inc. — Product Code JWH

K231947 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "EVOLUTION® Cement Keel". The FDA issued a decision of Substantially Equivalent on October 31, 2023. 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.