Device Dossier

Profix Inset Poly Patellar Component - Polyethylene patella prosthesis

Device Dossier for Profix Inset Poly Patellar Component - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor Smith &…

Intended purpose

A sterile patellar component of the Profix Total Knee System. Knee components are indicated for the following conditions: rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

Functional description

A polyethylene (UHMWPE) patellar component which is convex on both the articular and the fixation surfaces. The design maximizes polyethylene thickness at its central area which is often subjected to higher contact stress. The domed articular surface is congruent with the femoral component. It is intended to be implanted with bone cement.

TGA Public Summary