Summary for ARTG Entry:
Lima Orthopaedics Australia Pty Ltd - Lock Bipolar Head CoCrMo with UHMWPE Liner - Femoral head
ARTG entry for
Medical Device Included Class III
Lima Orthopaedics Australia Pty Ltd
Unit 1 40 Ricketts Road,MOUNT WAVERLEY, VIC, 3149
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.
Via Nazionale 52
Villanova San Daniele del Friuli, Udine, 33038
1. Lock Bipolar Head CoCrMo with UHMWPE Liner - Femoral head bipolar component
Single Device Product
33695 Femoral head bipolar component
The Lock bipolar heads are available in CCrMo alloy. The polished surface finish and the high congruence
to the acetablular cavity allows a natural fluency and adaptation to the chrondal surface. Each shell is
uniquely combined with a liner and a retentive ring all made of UHWMPE.
The lock bipolar heads are indicated in traumatic pathology of the head and the femoral neck in elder
patients. Degenerating pathologies of the hip with peculiar effect mostly to the femoral head such as a
vascular necroses disease. Special use for selected case of revision hip arthoplasty whereas a serious
acetablular deficiency still allow the maintenance of an adequate articulation congruency.
Diameter (mm) 41 to 57 mm Outer
Diameter (mm) 28 mm Inner
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 05:13:17 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information