LINK BiMobile Cup CL TiCap Shell, cementless, CoCrMo alloy, TiCaP Double Coating - Acetabular shell

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Link Orthopaedics Australia Pty Ltd
Class III
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


Link Orthopaedics Australia Pty Ltd - LINK BiMobile Cup CL TiCap Shell, cementless, CoCrMo alloy, TiCaP

Double Coating - Acetabular shell

ARTG entry for

Medical Device Included Class III


Link Orthopaedics Australia Pty Ltd

Postal Address

7/ 84 Poinciana Avenue,Tewantin, QLD, 4565


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Waldemar Link GmbH & Co KG

Barkhausenweg 10

Hamburg, , 22339



1. LINK BiMobile Cup CL TiCap Shell, cementless, CoCrMo alloy, TiCaP Double Coating - Acetabular shell

Product Type

Single Device Product

Effective date



43167 Acetabular shell

Functional description

Metal acetabular shell component of an acetabular replacement system used for cementless fixation in the

acetabulum in hip arthroplasty; made from biocompatible and resilient CoCrMo material with a mirror

polished on the inner surface to minimize wear; double coated with highly porous surface to achieve

primary fixation and an osteoconductive calcium phosphate coating, to ensure optimal primary and

secondary implant stability.

Intended purpose

Metal acetabular shell cementless component of the Link BiMobile Cup Dual Mobility System for the

treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or

osteosynthetic procedures

· Primary and secondary coxarthrosis

· Osteoarthritis

· Necrosis of the femoral head

· Femoral neck fractures

· Revision after implant loosening

· Acetabular dysplasia

Variant information

Diameter (mm) 42 - 70

Specific Conditions

© 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

Public Summary

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Produced at 08.11.2019 at 10:27:11 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.

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