TRIDENT

Main information

  • Trade name:
  • TRIDENT CUP X3 ACETABULAR INSERT - Non-constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • TRIDENT CUP X3 ACETABULAR INSERT - Non-constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219398
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219398

Stryker Australia Pty Ltd - TRIDENT CUP X3 ACETABULAR INSERT - Non-constrained polyethylene

acetabular liner

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

20/01/2014

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. TRIDENT CUP X3 ACETABULAR INSERT - Non-constrained polyethylene acetabular liner

Product Type

Single Device Product

Effective date

20/01/2014

GMDN

43168 Non-constrained polyethylene acetabular liner

Functional description

This Acetabular Insert is the inner portion of a two-piece acetabulum prosthesis that is sterile and made of

X3 polyethylene (highly cross-linked UHWMPE). Inserted into an Acetabular Shell, to articulate with an

artificial Femoral Head as part of a Total Hip Arthroplasty (THA). The insert allows rotational alignment

using 12 indexable scallops. Four alignment studs on the shell provide rotational and axial alignment.

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum.

Indications

· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis,

post-traumatic arthritis or late stage avascular necrosis.

· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

· Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely

to achieve satisfactory results.

· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by

deficiencies of the acetabulum.

Variant information

Diameter (mm) Inner 22mm to 44mm

Angle (In degrees) 0 and 10

Size A to J

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 07:42:35 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