GMK Sphere Primary Femur TiNbN Coated Cemented - Coated knee femur prosthesis

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Medacta Australia Pty Ltd

class:

Class III

manufactured_by:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

therapeutic_area:

33745 - Coated knee femur prosthesis

therapeutic_indication:

The GMK Sphere Primary Femur is TiNbN Coated and is designed for cemented use in total knee arthroplasty. The main purpose of the TiNbN coating is to limit the ion release from the underlying alloy. The design of the GMK Sphere is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial UHMWPE insert with a concave spherical medial compartment. This tibial-femoral combination allows the medial ?ball-in-socket? mechanism. Total Knee Prosthesis designed for tricompartmental replacement of the natural knee joint and intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure. If, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured, total knee replacement may be considered for young patients. This includes severely disabled patients with multiple joint involvement for whom and immediate gain in knee mobility may lead to significant improvement of their quality of life.

authorization_status:

A

authorization_date:

2019-08-26