LEGION HK Axle Plug - Rotating hinged total knee prosthesis - ARTG 480822
Access comprehensive regulatory information for LEGION HK Axle Plug - 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 480822 and sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc in United States of America. The device registration started on February 25, 2025.
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 LEGION HK Hinge Knee System is intended to be used with bone cement. Indications for Total Knee Replacement are: • Rheumatoid arthritis. • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. • Failed osteotomies or total knee replacement. • Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.