Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Solution Femoral Stems - Coated femoral stem
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class III
- 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.
Depuy Orthopaedics Inc
700 Orthopaedic Drive
Warsaw, IN, 46582
United States Of America
1. Solution Femoral Stems - Coated femoral stem prosthesis, modular
Single Device Product
34191 Coated femoral stem prosthesis, modular
Solution Femoral Stems are made from CoCr and have a 12/14 taper to accept a 12/14 tapered femoral
head. They are indicated for cementless use with fixation provided by biological tissue ingrowth into the
The Solution Femoral Stem is the femoral component in revision total hip arthroplasty which is intended to
provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in
patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,rheumatoid arthritis, or
congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty,
surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Size 6" - 10"
Shape Left or Right
Size (mm) 10.5 - 22.5
No Specific Conditions included on Record
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