EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) is an FDA 510(k)-cleared medical device (K251776) manufactured by Encore Medical L.P.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2025. Regulation: 8.