Device Dossier
Pinnacle 100 Acetabular Shell with Porocoat - Acetabular shell
Device Dossier for Pinnacle 100 Acetabular Shell with Porocoat - Acetabular shell (Acetabular shell, Class III, sponsor DePuy Synthes). ARTG record,…
- GMDN category: Acetabular shell
Intended purpose
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.
Functional description
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.