Device Dossier

GENESIS II Biconvex Patella - Polyethylene patella prosthesis

Device Dossier for GENESIS II Biconvex 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 an implant selected. A patellar reamer guide is used with a BLUE patellar depth gauge. Using the BLUE patellar depth gauge and reamer guide, ream until the depth stop engages the reamer guide. Following trialing, bone cement is applied to the reamed patella and the patellar implant is clamped onto it using a patellar cement clamp. Excess cement should be removed following initial fixation.

TGA Public Summary