Pinnacle 100 Acetabular Shell with Porocoat - Acetabular shell

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

class:

Class III

manufactured_by:

Depuy Orthopaedics Inc 700 Orthopaedic Drive, Warsaw, IN, 46582 United States Of America

therapeutic_area:

43167 - Acetabular shell

therapeutic_indication:

The Pinnacle Acetabular 100 Shells with Porocoat are titanium shells coated in Porocoat (titanium sintered beads) to enable biological fixation into the prepared acetabulum. An appropriate liner is then placed into the implanted shell. The Pinnacle 100 Acetabular Shell with Porocoat is an acetabular shell used during primary or revision total hip arthoplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

authorization_status:

A

authorization_date:

2014-03-25