Summary for ARTG Entry:
Amplitude Australia Pty Ltd - Cementless Saturne reconstruction dual mobility acetabular cup - Acetabular
ARTG entry for
Medical Device Included Class III
Amplitude Australia Pty Ltd
Level 7/263 Clarence Street,SYDNEY, NSW, 2000
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.
11 Cours Offenbach
Valence, , 26000
1. Acetabular shell
Single Device Product
43167 Acetabular shell
The cementless Saturne reconstruction dual mobility acetabular cups have a anti-dislocation shape,
flattened pole, equitorial press-fit, mirror polished inner surface with rounded edges.Constructed of
M25NW, with a double coating of titanium spray with HAP 80um. Upper acetabulum rim at the equator of
the shell has 2 flanges with two holes for use with cortical screws. Inferior acetabular rim has a positioning
hook located in the obturator hole. Interior is lined with a chamfer.
The Saturne reconstruction acetabular component is intended to be assembled with a femoral stem and
head to make a total hip prosthesis. Total Hip Arthroplasty is intended to reduce pain and increase hip
mobility in the treatment of degenerative disease or trauma of the hip.
Diameter (mm) 50-66
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:45:14 AEDT
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