Revitan® Proximal Body, Cylindrical - Press-fit hip femur prosthesis, modular
Access comprehensive regulatory information for Revitan® Proximal Body, Cylindrical - Press-fit hip femur prosthesis, modular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Zimmer Biomet Pty Ltd, manufactured by Zimmer GmbH in Switzerland. The device registration started on September 08, 2017.
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 Revitan® Proximal Cylindrical Body is intended to help to reduce pain and increase hip mobility through long-term uncemented fixation of total hip arthroplasty (THA) in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the revision of a previous joint replacement of the hip. The stem is intended to provide connection to specified ball heads, which articulate with the insert. Indication: Status following earlier operations, such as hemiarthroplasty or total hip prosthesis (THP); Revision of loosened total hip prostheses after the first implantation and after prosthetic replacement where extensive bone resorption has caused considerable widening of the medullary cavity with grave cortical bone thinning and the fixation of a new standard prosthesis is not possible; Revision of loosened total hip prostheses with fractures or cortical bone defects in the prosthetic bed.