510(k) K243656

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella by United Orthopedic Corporation — Product Code MBH

K243656 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.