510(k) K191325

EMPOWR Partial Knee by Encore Medical L.P. — Product Code HSX

K191325 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "EMPOWR Partial Knee". The FDA issued a decision of Substantially Equivalent on July 16, 2019. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Encore Medical L.P. has at least 10 other 510(k) clearances on record.