Paragon Hip System Femoral Stem PCHA, Collarless, Uncemented - Press-fit hip femur prosthesis, one-piece

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Corin Australia Pty Ltd

Klasse:

Class III

Fremstillet af:

Global Manufacturing Technology Pty Ltd 17 Bridge Street, Pymble, NSW, 2073 Australia

Terapeutisk område:

55834 - Press-fit hip femur prosthesis, one-piece

Terapeutiske indikationer:

The Paragon Stem PCHA is a cementless (press-fit) monoblock bi-planar femoral component of a joint replacement prosthesis to be used in total hip replacement surgery. The stem is made of Titanium Alloy, with a Hydroxyapatite (HA) and Titanium plasma composite coating to facilitate bony ingrowth to enhance fixation. The stem is to be used with a compatible femoral head and acetabular cup component. The stem is provided without a collar, and with or without RSA beads. Paragon Stem PCHA is part of The Paragon Hip System and is intended for use as the femoral component of a total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: 1. Degenerative osteoarthritis of the hip. 2. Inflammatory arthritis of the hip. 3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip). 4. Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse. 5. Avascular Necrosis of the femoral head.

Autorisation status:

A

Autorisation dato:

2017-11-09