Summary for ARTG Entry:
Zimmer Pty Ltd - ZCA® All-Poly Acetabular Cup, Flanged with Spacer - Polyethylene acetabulum
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. Polyethylene acetabulum prosthesis
Single Device Product
34076 Polyethylene acetabulum prosthesis
The acetabular cups are for use in primary or revision surgery. The Flanged Cup helps establish a stable
acetabular rim and helps pressurize cement. In addition, the flange can be easily trimmed to address
specific patient needs. They are made from ultra-high molecular-weight polyethylene (UHMWPE).
The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or
revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint
disease(NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped
capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Diameter (mm) 22-28 "Diameter of Reamed
Shape 10 degree Inclined Face
Angle (In degrees) 0-10
Size (mm) 43-61mm OD (Outer Diameter)
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:24:07 AEDT
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