Triathlon

Main information

  • Trade name:
  • Triathlon All Poly Tibial Component CS - Uncoated knee tibia prosthesis, polyethylene
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Triathlon All Poly Tibial Component CS - Uncoated knee tibia prosthesis, polyethylene
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220723
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220723

Stryker Australia Pty Ltd - Triathlon All Poly Tibial Component CS - Uncoated knee tibia prosthesis,

polyethylene

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

5/03/2014

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. Triathlon All Poly Tibial Component CS - Uncoated knee tibia prosthesis, polyethylene

Product Type

Single Device Product

Effective date

5/03/2014

GMDN

33580 Uncoated knee tibia prosthesis, polyethylene

Functional description

A sterile implantable all polyethylene tibial component, designed to be cemented into the tibia and to

articulate with an artificial femoral component for a Total Knee Arthroplasty (TKA).

Intended purpose

A tibial component of the Triathlon Total Knee used to replace the tibial plateau of the knee joint. General

Total Knee Arthroplasty (TKR) Indications: Painful, disabling joint disease of the knee resulting from:

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

necrosis), rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and

function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned

to adequate function and stability. Revision of previous unsuccessful knee replacement or other

procedure. Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture

management techniques.

Variant information

Size 1 - 8

Width (mm) Keel 42mm - 53mm

Length (mm) Keel 20mm - 28mm

Length (mm) A/P 40mm - 60mm

Length (mm) M/L 61mm - 85

Thickness 9mm - 16mm

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 03:21:06 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