Cobalt Chrome Modular Femoral Head - Metallic femoral head prosthesis

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Dostopno od:

Smith & Nephew Pty Ltd

Razred:

Class III

Izdeluje:

Smith & Nephew Inc Orthopaedic Division 1450 E Brooks Road, Memphis, TN, 38116 United States Of America

Terapevtsko območje:

33175 - Metallic femoral head prosthesis

Terapevtske indikacije:

A sterile implantable artificial femoral head that is made of a Cobalt Chrome alloy and is designed to mate with a titanium taper sleeve and articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. Modular heads are designed to fit on any Smith & Nephew femoral stem. The taper sleeve is firmly placed on the taper and the modular head is placed on the sleeve and impacted with a mallet. A sterile femoral head component of a total hip system. It attaches to a sleeve placed on the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Status dovoljenje:

A

Datum dovoljenje:

2013-12-05