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,…
- GMDN category: Rotating hinged total knee prosthesis
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.