BI-MENTUM Dual Mobility System Cemented Acetabular Cup - Acetabular shell
Access comprehensive regulatory information for BI-MENTUM Dual Mobility System Cemented Acetabular Cup - Acetabular shell in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Serf in France. The device registration started on April 23, 2021.
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.
Acetabular cups combining a “Cemented Cup” and a “PE Liner” are intended for the treatment of the following indications: osteoarthritis of the hip, fractures of the femoral neck, periacetabular metastatic disease, patients with a risk of instability (neurological, tumour, revision, dearthrodesis, cognitive issues, etc.), that could compromise the primary stability, particularly recommended in cases of osteoporotic bone, osteonecrosis, dysplasia, can be used for rehabilitation after severe Paprosky type IIIA and IIIB acetabular destruction, by cementing the cup in a fixed acetabular cage, can be used alone (without a fixed acetabular cage), when other acetabular cups are not appropriate, surgical revision (including recurrent dislocation and loosening) if the bone reconstruction allows, Paprosky type IIIA and IIIB bone defects.