510(k) K210961

U2 Total Knee System, XPE Tibial Insert, PS PLUS by United Orthopedic Corporation — Product Code JWH

K210961 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "U2 Total Knee System, XPE Tibial Insert, PS PLUS". The FDA issued a decision of Substantially Equivalent on April 21, 2021. 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. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.