Attune Knee System Revision LPS Insert AOX - Rotating hinged total knee prosthesis - ARTG 375180
Access comprehensive regulatory information for Attune Knee System Revision LPS Insert AOX - Rotating hinged total knee prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 375180 and sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy (Ireland) in Ireland. The device registration started on September 23, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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