Palacos

Main information

  • Trade name:
  • Palacos R+G pro - Cement, orthopaedic, bone
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Palacos R+G pro - Cement, orthopaedic, bone
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220925
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220925

Heraeus Medical Australia Pty Ltd - Palacos R+G pro - Cement, orthopaedic, bone

ARTG entry for

Medical Device Included Class III

Sponsor

Heraeus Medical Australia Pty Ltd

Postal Address

PO Box 800,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

7/03/2014

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

Heraeus Medical GmbH

8/13 Philipp-Ries Strasse

Wehrheim, , 61273

Germany

Products

1. Palacos R+G pro - Cement, orthopaedic, bone

Product Type

Single Device Product

Effective date

7/03/2014

GMDN

35217 Cement, orthopaedic, bone

Functional description

PALACOS R+G pro is the fast-curing radiopaque poly(methyl methacrylate) based PALACOS R+G bone

cement, packed in a closed mixing and application system ready-to-mix. Contains the antibiotic gentamicin

for protection of the cured cement and contiguous tissue against colonisation by microorganisms sensitive

to gentamicin. The cement is prepared directly before use by mixing a polymer powder component with a

liquid monomer component. This forms a ductile dough, which sets within a few minutes.

Intended purpose

PALACOS R+G pro is indicated for;

;· stable attachment of total or partial joint endoprostheses in bone

· filling and stabilising bone defects within the scope of internal fixation treatment or for endoprosthesis

exchange surgery

· primary and secondary coverage of skull bone defects

Variant information

Quantity/pack 45g - 60g (polymer powder)

Volume (mL) 22.5 - 30 (monomer liquid)

Quantity/pack 55g - 75g (Mixed Bone cement)

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 23.11.2017 at 08:19:24 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