510(k) K252725

Stem Extension Line (U2 Total Knee System—PSA Type) by United Orthopedic Corporation — Product Code JWH

K252725 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "Stem Extension Line (U2 Total Knee System—PSA Type)". The FDA issued a decision of Substantially Equivalent on September 25, 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. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.