510(k) K230169

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert by Encore Medical, L.P Dba Enovis — Product Code JWH

K230169 is an FDA 510(k) premarket notification submitted by Encore Medical, L.P Dba Enovis for the device "EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert". The FDA issued a decision of Substantially Equivalent on April 6, 2023. 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. Encore Medical, L.P Dba Enovis has at least 1 other 510(k) clearance on record.