510(k) K230120

KeYi Total Knee System by Beijing Keyi Medical Device Technology Co., Ltd. — Product Code JWH

K230120 is an FDA 510(k) premarket notification submitted by Beijing Keyi Medical Device Technology Co., Ltd. for the device "KeYi Total Knee System". The FDA issued a decision of Substantially Equivalent on April 19, 2024. 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. Beijing Keyi Medical Device Technology Co., Ltd. has at least 3 other 510(k) clearances on record.