510(k) K193549

SIGMA High Performance (HP) Partial Knee System by Depuy Ireland UC — Product Code HRY

K193549 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "SIGMA High Performance (HP) Partial Knee System". The FDA issued a decision of Substantially Equivalent on April 16, 2020. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Depuy Ireland UC has at least 10 other 510(k) clearances on record.