R3 Multi-hole Hemispherical Stiktite Coated Shell - Acetabular shell

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Smith & Nephew Pty Ltd

Klasse:

Class III

Produsert av:

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

Terapeutisk område:

43167 - Acetabular shell

Indikasjoner:

A titanium alloy (Ti-6Al-4V) hemispherical porous coated acetabular shell. The outer surface is coated with STIKTITE?, a sintered three-dimensional asymmetric titanium powder for enhanced scratch-fit feel and enhanced initial fixation. The shell has a polished inner surface to minimize backside wear. Following reaming of the acetabulum, the shell is impacted into place and has multiple holes for additional screw fixation if required. The R3 Multi-hole Hemispherical shell is an acetabular shell component of the cementless R3 Acetabular System. 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.

Autorisasjon status:

A

Autorisasjon dato:

2016-11-29