Device Dossier

Profix Conforming Plus Tibial Insert - Prosthesis, knee, internal, insert component

Device Dossier for Profix Conforming Plus Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

A UHMWPE articular insert of a total knee prosthesis. Indications for Total Knee Replacement include: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

Functional description

An implantable device designed to articulate with the cruciate retaining femoral component of a knee joint prosthesis during primary or revision knee joint replacement. The Profix Conforming Plus tibial insert has an anterior buildup stabilizing tibial articular surface. It is a one-piece contoured ultra-high molecular weight polyethylene (UHMWPE) insert which locks into the Profix tibial tray.

TGA Public Summary