510(k) K231037

MyKnee UNI-ST by Medacta International S.A. — Product Code JWH

K231037 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MyKnee UNI-ST". The FDA issued a decision of Substantially Equivalent on June 9, 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. Medacta International S.A. has at least 10 other 510(k) clearances on record.