Device Dossier

ADVANCE® Tri-Peg All-Poly Patella - Polyethylene patella prosthesis

Device Dossier for ADVANCE® Tri-Peg All-Poly Patella - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor MicroPort…

Intended purpose

A total knee system component intended to resurface the patella. Indications include use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis,; traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis.

Functional description

The subject device is an all-polyethylene patellar button used to resurface the patella and articulate with the knee femoral component. The subject devices feature 3 pegs for fixation and are available in 6 sizes ranging from 26 to 41mm.

TGA Public Summary