PROFEMUR® XM Classic Femoral Stem - Uncoated femoral stem prosthesis, one-piece - ARTG 473545
Access comprehensive regulatory information for PROFEMUR® XM Classic Femoral Stem - Uncoated femoral stem prosthesis, one-piece in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 473545 and sponsored by MicroPort Orthopedics Pty Ltd, manufactured by MicroPort Orthopedics Inc in United States of America. The device registration started on December 17, 2024.
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.
A total hip system component intended to replace the femur. Indications include use in cemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.