TRIATHLON

Main information

  • Trade name:
  • TRIATHLON TOTAL STABILISER (TS) FEMORAL COMPONENT - Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • TRIATHLON TOTAL STABILISER (TS) FEMORAL COMPONENT - Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217421
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217421

Stryker Australia Pty Ltd - TRIATHLON TOTAL STABILISER (TS) FEMORAL COMPONENT - Uncoated

knee femur prosthesis

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

18/11/2013

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. TRIATHLON TOTAL STABILISER (TS) FEMORAL COMPONENT - Uncoated knee femur prosthesis

Product Type

Single Device Product

Effective date

18/11/2013

GMDN

32831 Uncoated knee femur prosthesis

Functional description

The TS femoral component is for cemented use and is made of CoCr. It has been developed for mobility

with stability through 135 degrees of flexion. Design features such as a single radius, deep flexion radius

and flared posterior condyles, as well as an anatomic patellofemoral track allow the Triathlon TS knee

system to maintain substantial contact area throughout the entire range of motion.

Intended purpose

The total stabiliser femoral implant is a component of the Triathlon Total Knee intended for 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 stabilised by standard fracture management techniques. Additionally for ligamentous instability

requiring implant bearing surface geometries with increased constraint. Absent or non-functioning

Posterior Cruciate Ligament. Severe anteroposterior instability of the knee joint and for severe instability of

the knee secondary to compromised collateral ligament integrity or function.

Variant information

Shape Right

Shape Left

Width (mm) A/P 53mm - 75mm

Width (mm) Resected A/P 37mm - 58mm

Width (mm) M/L 59mm - 80mm

Size 1-8

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 02:25:05 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