DURACON

Main information

  • Trade name:
  • DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216479
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216479

Stryker Australia Pty Ltd - DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee

tibia prosthesis, metallic

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

23/10/2013

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee tibia prosthesis, metallic

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

A sterile implantable Tibial Tray/ Baseplate, designed to connect with a Tibial Insert that articulates with an

artificial Femoral Component of the Duracon Total Knee Arthroplasty (TKA) System. Keel Designed with

wide posteriorly angled fins, with the option for an extension stem to be attached, when required. Intended

for use with cement. Made of Cast Vitallium Alloy.

Intended purpose

A component of a reconstructive knee system that connects with a tibial insert that articulates with a

femoral knee component. Indications for use of total knee replacement prostheses include:

1) non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular

necrosis;

2) rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed;

5) post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or

prior patellectomy; and,

6) irreparable fracture of the knee.

Variant information

Length (mm) A/P 39mm - 60mm

Length (mm) M/L 64mm - 85mm

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 05:03:00 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