Summary for ARTG Entry:
Zimmer Pty Ltd - Uncoated hip femur prosthesis, modular
ARTG entry for
Medical Device Included (Export Only) Class 1
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class 1
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. Uncoated hip femur prosthesis, modular
Single Device Product
34190 Uncoated hip femur prosthesis, modular
Indicated for Total hip arthroplasty for patients with:
± Severe hip pain and disability due to rheumatoid arthritis,
osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders,
avascular necrosis of the femoral head, and nonunion of previous
fractures of the femur.
± Congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral
± Disability due to previous fusion.
± Previously failed endoprostheses and/or total hip components in the
± Acute femoral neck fractures.
· Hemi-hip arthroplasty is indicated for:
± Fracture dislocation of the hip.
± Elderly, debilitated patients when a total hip replacement is
± Irreducible fractures in which adequate fixation cannot be obtained.
± Certain high subcapital fractures and comminuted femoral fractures in
± Nonunion of femoral neck fractures.
± Secondary avascular necrosis of the femoral head.
± Pathological fractures of the femoral neck.
± Osteoarthritis in which the femoral head is primarily affected.
No Specific Conditions included on Record
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