Summary for ARTG Entry:
Heraeus Medical Australia Pty Ltd - Palacos R+G pro - Cement, orthopaedic, bone
ARTG entry for
Medical Device Included Class III
Heraeus Medical Australia Pty Ltd
PO Box 800,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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.
Heraeus Medical GmbH
8/13 Philipp-Ries Strasse
Wehrheim, , 61273
1. Palacos R+G pro - Cement, orthopaedic, bone
Single Device Product
35217 Cement, orthopaedic, bone
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.
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
· primary and secondary coverage of skull bone defects
Quantity/pack 45g - 60g (polymer powder)
Volume (mL) 22.5 - 30 (monomer liquid)
Quantity/pack 55g - 75g (Mixed Bone cement)
No Specific Conditions included on Record
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