Device Dossier

ADVANCE® Recessed All-Poly Patella - Polyethylene patella prosthesis

Device Dossier for ADVANCE® Recessed 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 two variants both feature the same articulating surface geometry and differ only by size and thickness.

TGA Public Summary