Uncoated

Main information

  • Trade name:
  • Uncoated hip femur prosthesis, modular
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uncoated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222852
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222852

Zimmer Pty Ltd - Uncoated hip femur prosthesis, modular

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

28/04/2014

Product category

Medical Device Class 1

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

Zimmer Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. Uncoated hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

28/04/2014

GMDN

34190 Uncoated hip femur prosthesis, modular

Intended purpose

Indicated for Total hip arthroplasty for patients with:

± Severe hip pain and disability due to rheumatoid arthritis,

osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders,

avascular necrosis of the femoral head, and nonunion of previous

fractures of the femur.

± Congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral

epiphysis.

± Disability due to previous fusion.

± Previously failed endoprostheses and/or total hip components in the

affected extremity.

± Acute femoral neck fractures.

· Hemi-hip arthroplasty is indicated for:

± Fracture dislocation of the hip.

± Elderly, debilitated patients when a total hip replacement is

contraindicated.

± Irreducible fractures in which adequate fixation cannot be obtained.

± Certain high subcapital fractures and comminuted femoral fractures in

the aged.

± Nonunion of femoral neck fractures.

± Secondary avascular necrosis of the femoral head.

± Pathological fractures of the femoral neck.

± Osteoarthritis in which the femoral head is primarily affected.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 09.11.2017 at 07:28:37 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