Main information

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



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220722
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


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


ARTG entry for

Medical Device Included Class III


Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America


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

Product Type

Single Device Product

Effective date



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. Additional Indications for Posterior Stabilized (PS) Components: Ligamentous

instability requiring implant bearing surface geometries with increased constraint. Absent or

non-functioning Posterior Cruciate Ligament. Severe anteroposterior instability of the knee joint.

Variant information

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

Length (mm) Keel 20mm - 28mm

Width (mm) Keel 42mm - 53mm

Size 1 - 8

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 03:21:22 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.

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