Summary for ARTG Entry:
Adler Ortho Australia Pty Ltd - CORAE Cementless HA Coated Monobloc Stem Neck - Coated hip femur
ARTG entry for
Medical Device Included Class III
Adler Ortho Australia Pty Ltd
PO Box 1770,Capalaba, QLD, 4157
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.
Adler Ortho Srl
9 Via dell'innovazione
Cormano, MI, 20032
1. CORAE Cementless HA Coated Monobloc Stem Neck - Coated hip femur prosthesis, modular
Single Device Product
33581 Coated hip femur prosthesis, modular
Forged titanium alloy implants. Surface is HA coated at 80 microns +/- 20M?. Available in 10 sizes with
progressive dimensional growth. The first 8 sizes feature 2 offset options, to allow accurate hip
biomechanics restoration. Proximally the stem has several transversal parallel grooves, while distally it has
longitudinal ridges. This feature maximizes bone implant contact area and improves prosthesis secondary
fixation. All Corae stems feature a proximal; threaded hole for axial impaction.
The CORAE stem is a straight-tapered monoblock femoral component intended for use in primary hip
replacement procedures. It is designed to connect to a suitable femoral head implant and together replace
the femoral head and neck and function as part of a total hip replacement prosthesis.
Indicated for use in;
- Primary and secondary arthrosis
- Rheumatoid and degenerative arthritis
- Deformities, such as dysplasia
- Fractures and necrosis of bone
- Revisions, where other devices or treatments have failed
- Metastatic diseases
Angle (In degrees) CCD 130 - 135
Size 9 - 18
Offset Standard Stem and 5mm offset stem
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.
Page 1 of
Produced at 10.11.2017 at 05:29:43 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