Echelon Porous Plus HA Standard Collar Femoral Component - Coated femoral stem prosthesis, modular

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
09-11-2017

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:

34191 - Coated femoral stem prosthesis, modular

Terapevtske indikacije:

A Cobalt Chrome straight femoral stem with a RoughCoat porous plus hydroxyapatite coating to the implant tip. The stem has a standard collar, a circulotrapezoidal neck providing an increased range of motion, a threaded driving platform with an elliptical slot for rotational and axial implant control during insertion. Following sequential reaming and broaching of the femur, the calcar is reamed and the stem trialed. The stem is impacted into place using a threaded stem inserter and a mallet. The ECHELON Porous Plus HA Standard Collar stem is a femoral component of a total revision hip 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.

Status dovoljenje:

A

Datum dovoljenje:

2014-04-16

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