Device Dossier
OrthoCentric Acetabular Shell - Acetabular shell
Device Dossier for OrthoCentric Acetabular Shell - Acetabular shell (Acetabular shell, Class III, sponsor OrthoCentric). ARTG record, intended purpose,…
- GMDN category: Acetabular shell
Intended purpose
The OrthoCentric Acetabular Shell is a component of an acetabular system (cup) made of two components: an Acetabular Shell and a Liner. It is supplied sterile. The OrthoCentric Acetabular Shell is intended for use in total hip arthroplasty. Total hip arthroplasty (THA) is indicated for a hip joint replacement in order to provide increased patient mobility and reduce pain where there is evidence of sufficient sound bone to seat and support the components. Treatment selection for his patient is the surgeon’s responsibility. When a surgeon has selected total hip arthroplasty as the preferred treatment, the devices are indicated for: - Osteoarthritis or post traumatic osteoarthritis - Rheumatoid arthritis. - Correction of functional deformity. - Avascular necrosis of the femoral head or neck. - Acute traumatic fracture of the femoral head or neck. - Revision of any unsuccessful previous hip surgery or where other treatments or devices have failed. - Certain cases of ankylosis. - Hip dysplasia (painful or congenital) - Severely painful and/or disabled joint The acetabular components are intended for cementless fixation.
Functional description
The Orthocentric Acetabular Shell wedges tightly into the reshaped natural socket and allows new bone to quickly form and grow into its outer surface. Additionally, a ceramic or cross-linked polyethylene liner is fitted into the shell. Upon implantation, the assembly of these components is designed to replace the natural articulation of the hip joint. MRI Not Tested