MRH Tibial

Main information

  • Trade name:
  • MRH Tibial Bearing Component (Reverse Crossover) - Rotating hinged total knee prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • MRH Tibial Bearing Component (Reverse Crossover) - Rotating hinged total knee prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222421
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222421

Stryker Australia Pty Ltd - MRH Tibial Bearing Component (Reverse Crossover) - Rotating hinged total

knee 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

11/04/2014

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. MRH Tibial Bearing Component (Reverse Crossover) - Rotating hinged total knee prosthesis

Product Type

Single Device Product

Effective date

11/04/2014

GMDN

33692 Rotating hinged total knee prosthesis

Functional description

This Tibial Bearing component is assembled intraoperatively with a set of bushings and an axle, a bumper

locks this assembly (supplied separately). This assembly provides motion through the axle/bushing

combination in the flexion/extension plane. The stem of the tibial bearing component fits into the

polyethylene tibial component or insert which is fixed to the tibia, providing motion in the rotational plane

and translation in the axial plane. Made from forged VITALLIUM Alloy.

Intended purpose

A tibial bearing component of a Modular Rotating Hinge Knee System, intended to be implanted in the

following condition(s):

1. There is destruction of the joint surfaces, with or without significant bone deformity.

2. The cruciate and/or collateral ligaments do not stabilize the knee joint.

3. The ligaments are inadequate and/or the musculature is weak. And/or,

4. Revision is required of a failed prostheses where there has been gross instability, with or without bone

loss or inadequate soft tissue

Variant information

Nil variant (as 1 device) Nil

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 09.11.2017 at 09:38:24 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