RHK knee

Main information

  • Trade name:
  • RHK knee rotating tibial bearing - Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • RHK knee rotating tibial bearing - Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222367
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222367

Zimmer Pty Ltd - RHK knee rotating tibial bearing - Prosthesis, knee, internal, insert component

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

10/04/2014

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

Biomet UK Ltd

Waterton Industrial Estate

Bridgend, South Glamorgan, CF31 3XA

Products

1. RHK knee rotating tibial bearing - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

10/04/2014

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

Bi-helical design Arcom rotating bearing which articulates on the highly polished cobalt chrome tibial tray.

Large femoral contact area with enhanced range of motion, maintaining full contact up to 155 degrees of

flexion.

Intended purpose

Arcom tibial bearing component of the Rotating Hinge Knee salvage knee prosthesis. Indications for use

include: significant bone loss; gross ligamentous deficiencies; oncological bone replacement (primary or

metastatic); salvage knee arthroplasty; trauma; connective tissue disorders.

Variant information

Size 12-20

Size For 63-67MM tray

Size For 71-75MM tray

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 09:52:50 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