Device Dossier

Triathlon CR Beaded Femoral Component w/ PA (L and R) - Coated knee femur prosthesis

Device Dossier for Triathlon CR Beaded Femoral Component w/ PA (L and R) - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor…

Intended purpose

The Cruciate Retaining Beaded Femoral Component with PA coating implant is a component of the Triathlon Total Knee System. General Primary Total Knee Arthroplasty (TKA) indications include: Painful, disabling joint disease of the knee resulting from: noninflammatory 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

This Total Knee System includes femoral, patella, tibial tray, tibal bearing and bone augmentation components which are designed to be used together to achieve total reconstructive replacement of the knee joint. These femoral components are permanently implantable and are available in various sizes to address varying patient and surgeon requirements for primary and revision applications. All devices feature a coating of PA on their external surface to encourage bone in growth.

TGA Public Summary