Device Dossier

GENESIS II Resurfacing Patella - Polyethylene patella prosthesis

Device Dossier for GENESIS II Resurfacing Patella - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor Smith & Nephew).…

Intended purpose

1.Rheumatoid arthritis. 2.Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3.Failed, unicompartmental replacement, or total knee replacement.

Functional description

A polyethylene patellar implant designed to be cemented onto a reamed patella. The patella is measured and cut using the dedicated saw guides and resurfacing technique of choice. Fixation holes are drilled and the trial is fitted onto the patella. Bone cement is applied to the patellar implant and the implant is clamped onto the reamed patella using a patellar cement clamp. Excess cement should be removed following initial fixation.

TGA Public Summary