Australia TGA ARTG recordBI-MENTUM Dual Mobility System Cemented Acetabular Cup - Acetabular shell
Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes · Serf · Class III · Started April 23, 2021
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - BI-MENTUM Dual Mobility System Cemented Acetabular Cup - Acetabular shell
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 23, 2021
- Effective Date
- April 23, 2021
- Name
- Serf
- Country
- France
- Address
- 85 Avenue des Bruyeres, Decines, 69153
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.
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.
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