balanSys vitamys RP Inlay - Bicompartmental knee prosthesis - ARTG 312507
Access comprehensive regulatory information for balanSys vitamys RP Inlay - Bicompartmental 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 312507 and sponsored by Mathys Orthopaedics Pty Ltd, manufactured by Mathys Ltd Bettlach in Switzerland. The device registration started on December 14, 2018.
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 balanSys Bicondylar prosthesis is intended for treating degenerative joint diseases of the knee joint in skeletally mature patients. Indications include: - Painful and / or disabling joint disease of the knee resulting from osteoarthritis, avascular necrosis, inflammatory arthritis or post-traumatic arthritis - Revision of previous knee replacement - Fracture of the distal femur and / or proximal tibia that cannot be stabilized by standard fracture management techniques