Device Dossier

Pinnacle 100 Acetabular Shell with Gription - Acetabular shell

Device Dossier for Pinnacle 100 Acetabular Shell with Gription - Acetabular shell (Acetabular shell, Class III, sponsor DePuy Synthes). ARTG record,…

Intended purpose

The Pinnacle 100 Acetabular Shell with Gription is the acetabular shell component used during primary or revision total hip arthroplasty 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.

Functional description

The Pinnacle 100 Acetabular Shells with Gription are titanium shells coated in Gription to enable biological, cementless fixation into the prepared acetabulum. An appropriate liner is placed into the shell.

TGA Public Summary