Prosthesis

Main information

  • Trade name:
  • Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218199
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218199

Stryker Australia Pty Ltd - DURACON TOTAL STABLIZER (TS) CONSTRAINED TIBIAL INSERT -

Prosthesis, knee, internal, insert component

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

6/12/2013

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. Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

6/12/2013

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

Sterile Tibial Insert designed to connect with tibial tray for fixation and articulate with Femoral Component

for a Total Knee Arthroplasty. Constrained intercondylar insert indicated in revisions where loss of one or

both collateral ligaments or inability to balance collateral ligaments in flexion & extension. With a highly

conforming tibiofemoral articulation. Tall tibial spine reinforced with preassembled Vitallium Alloy support

post to resist varus/valgus forces Made of Polyethylene (UHMWPE)

Intended purpose

A component of reconstructive knee system, connects with a tibial base plate and articulates with a

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

1) noninflammatory 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

Size Small

Size Ex Large

Size Large

Size Medium

Thickness 11mm to 31mm

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 11:27:09 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