Lock

Main information

  • Trade name:
  • Lock Bipolar Head CoCrMo with UHMWPE Liner - Femoral head bipolar component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Lock Bipolar Head CoCrMo with UHMWPE Liner - Femoral head bipolar component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216354
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216354

Lima Orthopaedics Australia Pty Ltd - Lock Bipolar Head CoCrMo with UHMWPE Liner - Femoral head

bipolar component

ARTG entry for

Medical Device Included Class III

Sponsor

Lima Orthopaedics Australia Pty Ltd

Postal Address

Unit 1 40 Ricketts Road,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

23/10/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Limacorporate Spa

Via Nazionale 52

Villanova San Daniele del Friuli, Udine, 33038

Italy

Products

1. Lock Bipolar Head CoCrMo with UHMWPE Liner - Femoral head bipolar component

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

33695 Femoral head bipolar component

Functional description

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.

Intended purpose

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.

Variant information

Diameter (mm) 41 to 57 mm Outer

Diameter (mm) 28 mm Inner

Specific Conditions

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.

Public Summary

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

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