Device Dossier

ATTUNE Revision Tibial Base Fixed Bearing - Uncoated knee tibia prosthesis, metallic

Device Dossier for ATTUNE Revision Tibial Base Fixed Bearing - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

The ATTUNE Revision Tibial Base Fixed Bearing is a component of the ATTUNE Revision Knee System which is used in Total Knee Arthroplasty (TKA). The ATTUNE Revision Knee System is intended to provide a functional articulating knee joint in skeletally mature patients with a severe painful knee and impaired knee function and/or after a failed previous implant. It is indicated for: 1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease) 2. Failed previous knee surgery, typically unsuccessful knee replacement, osteotomy or other knee procedures 3. TKA patients with ligamentous insufficiency and/or bone loss which, in the clinical judgement of the surgeon, requires increased bearing constraint and/or supplemental fixation.

Functional description

The ATTUNE Revision Tibial Base Fixed Bearing is manufactured from Co-Cr-Mo alloy and includes a Ti-6Al-4V removable end cap. The surface is textured for cemented fixation. A central, universal locking mechanism is utilized that engages the anterior and posterior tabs in the ATTUNE FB CR and PS Tibial Inserts. It is possible to affix an optional stem on the base by removing the end cap where additional stability is deemed appropriate based on individual patient needs.

TGA Public Summary