Device Dossier

EMPOWR 3D Knee Femur Non-porous - Coated knee femur prosthesis

Device Dossier for EMPOWR 3D Knee Femur Non-porous - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

Device is intended for treatment of adult patients who are candidates for primary total knee arthroplasty. Device is indicated for use as a total knee replacement for the relief of pain and significant disability resulting from degenerative joint diseases such as primary or secondary osteoarthritis or rheumatoid arthritis. Device is indicated for cemented applications.