Device Dossier

TRIATHLON X3 CRUCIATE RETAINING (CR) TIBIAL INSERT - Prosthesis, knee, internal, insert component

Device Dossier for TRIATHLON X3 CRUCIATE RETAINING (CR) TIBIAL INSERT - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The cruciate retaining tibial insert is a component of the Triathlon total Knee System. General Total Knee Arthroplasty (TKA) Indications include: Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease; Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; Revision of previous unsuccessful knee replacement or other procedure.

Functional description

A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and to articulate with an artificial Femoral Component of a Total Knee Arthroplasty (TKA). Designed to be implanted with retention of the Posterior Cruciate Ligament. It is a component of the Triathlon Knee System which typically includes Femoral, Tibial, and Patellar components that articulate. Made of X3 polyethylene (highly cross-linked UHWMPE).

TGA Public Summary