CORAE

Main information

  • Trade name:
  • CORAE Cementless HA Coated Monobloc Stem Neck - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CORAE Cementless HA Coated Monobloc Stem Neck - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216269
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216269

Adler Ortho Australia Pty Ltd - CORAE Cementless HA Coated Monobloc Stem Neck - Coated hip femur

prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Adler Ortho Australia Pty Ltd

Postal Address

PO Box 1770,Capalaba, QLD, 4157

Australia

ARTG Start Date

21/10/2013

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

Adler Ortho Srl

9 Via dell'innovazione

Cormano, MI, 20032

Italy

Products

1. CORAE Cementless HA Coated Monobloc Stem Neck - Coated hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

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.

Intended purpose

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

Variant information

Angle (In degrees) CCD 130 - 135

Size 9 - 18

Offset Standard Stem and 5mm offset stem

Taper 12/14

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 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