Trilogy

Main information

  • Trade name:
  • Trilogy® Longevity Highly Crosslinked Polyethylene Constrained Liners - Constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Trilogy® Longevity Highly Crosslinked Polyethylene Constrained Liners - Constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218867
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218867

Zimmer Pty Ltd - Trilogy® Longevity Highly Crosslinked Polyethylene Constrained Liners - Constrained

polyethylene 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

2/01/2014

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 Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. Trilogy® Longevity Highly Crosslinked Polyethylene Constrained Liners - Constrained polyethylene

acetabular liner

Product Type

Single Device Product

Effective date

2/01/2014

GMDN

44362 Constrained polyethylene acetabular liner

Functional description

Liner consists of UHMWPE liner and a Tivanium® Ti-6Al-4V alloy constraining ring. It fits into the metal

shell and articulates with the femoral heads. The Liner features two fingers which extend beyond the

equator of the shell to mechanically capture the femoral head. The constraining ring snaps onto the liner to

reinforce capture of the femoral head within the liner.

Intended purpose

The Trilogy Longevity Constrained Liner is indicated as a component of a total hip prosthesis in primary or

revision total

hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint,

muscle

or tissue laxity, or disease condition. This device is intended for patients for whom all other options to

constrained

acetabular components have been considered.

Variant information

Thickness (50mm OD x 28mm ID) - (80mm OD x

36mm ID)

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 09:05:19 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