Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - S-ROM ZTT Proximal Sleeve - Coated hip femur
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. S-ROM ZTT Proximal Sleeve - Coated hip femur prosthesis, modular
Single Device Product
33581 Coated hip femur prosthesis, modular
The S-ROM ZTT Proximal Sleeves are made out of Titanium and are porous coated for cementless use
only. The S-ROM ZTT Proximal Sleeves are used with the S-ROM femoral stem to help achieve proximal
fill during hip arthroplasty.
The S-ROM ZTT Proximal Sleeves are used with the S-ROM femoral stem to help achieve proximal fill.
The components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures
for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid
arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of
femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for
patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability
due to previous fusion.
Size 12 - 24
Size B or D or F
No Specific Conditions included on Record
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