Device Dossier

ETS Hip Endoprosthesis - Uncoated hip femur prosthesis, one-piece

Device Dossier for ETS Hip Endoprosthesis - Uncoated hip femur prosthesis, one-piece (Uncoated hip femur prosthesis, one-piece, Class III, sponsor…

Intended purpose

Intended for cemented hip hemiarthroplasty for the following indications: 1. non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of non union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Functional description

A sterile collarless monoblock hemiarthroplasty device manufactured from Stainless Steel and available in a range of outer diameter head sizes. Packaged with two PMMA spacers.

TGA Public Summary