Device Dossier

Patella, Domed Tri-Peg, E+ - Polyethylene patella prosthesis

Device Dossier for Patella, Domed Tri-Peg, E+ - Polyethylene patella prosthesis (Polyethylene patella 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.