ARTG 476628LEGION HK Femur Axle - Rotating hinged total knee prosthesis
ARTG ID: 476628 · Smith & Nephew Pty Ltd · Smith & Nephew Inc · Class III · Started January 24, 2025
Good Name: Smith & Nephew Pty Ltd - LEGION HK Femur Axle - Rotating hinged total knee prosthesis
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 476628
- Start Date
- January 24, 2025
- Effective Date
- January 24, 2025
- Country
- United States of America
- Address
- 1450 Brooks Rd, Memphis, Tennessee, 38116
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.
Access comprehensive regulatory information for LEGION HK Femur Axle - 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 476628 and sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc in United States of America. The device registration started on January 24, 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.