Device Dossier

Triathlon Revision Insert X3 - Prosthesis, knee, internal, insert component

Device Dossier for Triathlon Revision Insert X3 - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

Intended purpose

The Triathlon Revision Insert X3 is intended for General Primary Knee Arthroplasty (TKA) Indications: - 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. Additional Indications for Total Stabilizer (TS) Components: - Revision of previous unsuccessful knee replacement or other procedure. The following indications apply in complex primary and/or revision Total Knee Arthroplasty: - Ligamentous instability requiring implant bearing surface geometries with increased constraint. - Absent or non-functioning posterior cruciate ligament. - Severe anteroposterior instability of the knee joint. - Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Functional description

The Triathlon Revision Insert X3 is a component of the Triathlon Total Knee System, designed to be used in total reconstructive replacement of the knee joint. The tibial inserts are available in total stabilizing (TS) design. Tibial inserts are available in a range of thicknesses and are provided with a stabilizer pin and filler bushing subcomponents.

TGA Public Summary