Uncoated

Main information

  • Trade name:
  • Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217949
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217949

Stryker Australia Pty Ltd - SERIES 7000 TIBIA TRAY - 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

2/12/2013

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. Uncoated knee tibia prosthesis, metallic

Product Type

Single Device Product

Effective date

2/12/2013

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

A sterile implantable Tibial Tray/ Baseplate, designed to house a Cruciate Retaining or Posteriorly

Stabilised Tibial Insert that articulates with an artificial Femoral Component of the Series 7000 Total Knee

Arthroplasty (TKA) System. A waffle design, no screw holes, keel and with the option for an extension

stem to be attached, when required. Intended for use with cement. Made of Cobalt Chrome.

Intended purpose

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

articulates with a femoral knee component. Indications

· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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.

Variant information

Thickness M/L 61mm - 88mm

Thickness A/P 40mm - 58mm

Model number (see guidance docs) 7115003 -

71150013

Size 3 - 13

Length (mm) Stem 30mm - 40mm

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 12:29:03 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