Device Dossier

ATTUNE Revision CRS Femoral Cemented - Uncoated knee femur prosthesis

Device Dossier for ATTUNE Revision CRS Femoral Cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor DePuy…

Intended purpose

The ATTUNE Revision Constrained Revision System (CRS) Femur 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 CRS Femur is manufactured from Co-Cr-MO alloy without a porous coating and has an asymmetric trochlear groove. It is intended to restore the tibiofemoral and patellofemoral articulating surface and provides a rigid condylar surface to replace native bone and articulate with poly bearing surface. Includes a UHMWPE plug and is intended for cemented fixation.

TGA Public Summary