Main information

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



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

Other information


  • 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:


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


ARTG entry for

Medical Device Included Class III


Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086


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.




Zimmer Inc

1800 West Center Street


United States Of America


1. Polyethylene acetabulum prosthesis

Product Type

Single Device Product

Effective date



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


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


Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications


EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety