Polyethylene

Main information

  • Trade name:
  • Polyethylene acetabulum prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Polyethylene acetabulum prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217425
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217425

Zimmer Pty Ltd - ZCA® All-Poly Acetabular Cup, Flanged with Spacer - Polyethylene acetabulum

prosthesis

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

18/11/2013

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

Zimmer Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. Polyethylene acetabulum prosthesis

Product Type

Single Device Product

Effective date

18/11/2013

GMDN

34076 Polyethylene acetabulum prosthesis

Functional description

The acetabular cups are for use in primary or revision surgery. The Flanged Cup helps establish a stable

acetabular rim and helps pressurize cement. In addition, the flange can be easily trimmed to address

specific patient needs. They are made from ultra-high molecular-weight polyethylene (UHMWPE).

Intended purpose

The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or

revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint

disease(NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped

capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Variant information

Diameter (mm) 22-28 "Diameter of Reamed

Acetabulum"

Shape 10 degree Inclined Face

Angle (In degrees) 0-10

Size (mm) 43-61mm OD (Outer Diameter)

Shape Neutral

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 02:24:07 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

9-11-2018

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