Device Dossier

EP-FIT PLUS XLPE - Non-constrained polyethylene acetabular liner

Device Dossier for EP-FIT PLUS XLPE - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III, sponsor…

Intended purpose

Smith&Nephew total hip prosthesis is intended to replace a hip joint. Indications • Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. • Fracture or avascular necrosis of the femoral head • Conditions resulting from previous operations, such as osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty or hip total prosthesis (not applicable for SBG stem).

Functional description

An acetabular Liner, standards are sterile implantable devices manufactured from crosslinked polyethylene (XLPE). Locking tabs facilitate ease of insertion and provide anti-rotational stability while a snap in rim secures the liner into the shell.

TGA Public Summary