HYPE SC cementless stem - Press-fit femoral stem prosthesis - ARTG 482045
Access comprehensive regulatory information for HYPE SC cementless stem - Press-fit femoral stem prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 482045 and sponsored by Compliance Management Solutions, manufactured by Serf in France. The device registration started on March 07, 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.
Hype® SC cementless hip stems are designed to be implanted in the context of a first-line total hip replacement in order to relieve pain and restore the mobility of the hip. Indications are: – primary or secondary osteoarthritis, – avascular necrosis, – femoral neck fracture, – dysplasia, for skeletally mature adults (usually aged 65 and over), suffering from extreme pain and/or a disabled joint caused by a medical condition that was diagnosed at an earlier time and insufficiently improved by a correctly carried out medical treatment, after an observation period lasting from a few weeks to a few months.