Cerasul

Main information

  • Trade name:
  • Cerasul Alpha Inserts - Ceramic acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cerasul Alpha Inserts - Ceramic acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220399
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220399

Zimmer Biomet Pty Ltd - Cerasul Alpha Inserts - Ceramic acetabular liner

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

24/02/2014

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

Zimmer GmbH

Sulzer Allee 8

, Winterthur, CH-8404

Switzerland

Products

1. Cerasul Alpha Inserts - Ceramic acetabular liner

Product Type

Single Device Product

Effective date

24/02/2014

GMDN

48055 Ceramic acetabular liner

Functional description

An Insert component of the The Allofit®/Allofit®-S Alloclassic® Cup System for articulation with the

appropriate cup (shell and Insert) and femoral head component in the treatment of degenerative disease.

Manufactured from Ultra-High Molecular Weight (Sulene®-PE) ISO 5834-2 and aluminum oxide

(Cerasul®) ceramic ISO 6474. They are indicated for uncemented, press-fit use. The diameter of the

device is 28mm.

Intended purpose

· Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and

inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

· Failed previous surgery where pain, deformity, or dysfunction persists.

· Revision of previously failed hip arthroplasty.

· Total hip replacements may be considered for younger patients if any unequivocal indication outweighs

the risks associated with the age of the patient and modified demands regarding activity and hip joint

loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom

an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their

lives..

Variant information

Size II - QU

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 04:13:01 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