Device Dossier

OrthoCentric Hip Stem, Cemented - Uncoated hip femur prosthesis, modular

Device Dossier for OrthoCentric Hip Stem, Cemented - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor…

Intended purpose

The OrthoCentric Hip Stem, Cemented is a component of a femoral system made of two components: a Hip Stem, Cemented and a BIOLOX® Delta ZTA Ceramic Head . It is supplied sterile. The OrthoCentric Hip Stem, Cemented 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 their 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 OrthoCentric Hip Stem, Cemented is intended for use with bone cement.

Functional description

The OrthoCentric Hip Stem, Cemented. is designed to place the centre of rotation at the native hip centre. In order for this to occur the vertical height, medial offset, and version of femoral region should be appropriate. A femoral head connects to the femoral neck. Upon implantation, the assembly of these components is designed to replace the natural articulation of the hip joint. MRI Not Tested

TGA Public Summary