Device Dossier

Attune Knee System Revision LPS Insert AOX - Rotating hinged total knee prosthesis

Device Dossier for Attune Knee System Revision LPS Insert AOX - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…

Intended purpose

The Attune Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal and/or total femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: • malignant tumours (e.g. osteosarcomas, chondrosarcomas, giant cell tumors, bone tumours) requiring extensive resection and replacement • patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement • revision cases for a failed previous prosthesis requiring extensive resection and replacement • severe trauma requiring extensive resection and replacement • post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required

Functional description

The Attune Revision LPS Insert provides a smooth surface to replace the tibial plateau and articulate with the condylar surface of the femoral component when used in conjunction with a femoral, tibial, patellar and other associated prosthesis as required. It consists of an AOX Antioxidant UHMWPE bearing, AOX Antioxidant UHMWPE bushings, and a forged cobalt chrome molybdenum hinge post. The hinge pin secures the insert to the distal femoral component to provide stability in flexion and extension.

TGA Public Summary