Pinnacle Acetabular Shells with Gription - Acetabular Shell

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

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 indications:

The Pinnacle Acetabular Shells with Gription are titanium shells coated in Gription (titanium sintered particles on a titanium sintered beads substrate) to enable cementless, biological fixation into the prepared acetabulum. Additionally, the Pinnacle Acetabular Shells with Gription are available with of a range of holes to allow screws. An appropriate liner is then placed into the implanted shell. The Pinnacle Acetabular Shell with Gription is the acetabular shell component 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:

2015-04-28