Device Dossier

ABG II Femoral Stem with HA - Prosthesis, internal, joint, hip, femoral component

Device Dossier for ABG II Femoral Stem with HA - Prosthesis, internal, joint, hip, femoral component (Prosthesis, internal, joint, hip, femoral…

Intended purpose

The indications for use of total hip replacement prostheses include: • Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup); • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and, • Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Functional description

These cementless femoral stems are permanently implantable and are available in various sizes to address varying individual patient femoral physiology. All stems are made of a TMZF Alloy and feature a proximal coating of Hydroxyapatite (HA) on their external surface to encourage bone in growth.

TGA Public Summary