Sigma CR150 Femur - Uncoated knee femur prosthesis
Access comprehensive regulatory information for Sigma CR150 Femur - Uncoated knee femur prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy (Ireland) in Ireland. The device registration started on May 19, 2020.
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 Sigma CR150 Femur is one component of a Total or unicompartmental knee arthroplasty which is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total or unicompartmental knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total or unicompartmental knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.