GENUS FB cementless tibial tray Ti-Por+HA coated - Coated knee tibia prosthesis

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Adler Ortho Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
291771

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Public Summary

Summary for ARTG Entry:

291771

Adler Ortho Australia Pty Ltd - GENUS FB cementless tibial tray Ti-Por+HA coated - Coated knee tibia

prosthesis

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

20/07/2017

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. GENUS FB cementless tibial tray Ti-Por+HA coated - Coated knee tibia prosthesis

Product Type

Single Device Product

Effective date

20/07/2017

GMDN

34198 Coated knee tibia prosthesis

Functional description

Ti6Al4V with porous titanium & HA coating. A fixed-bearing tibial component showing a non-anatomical

shape and a keel to be anchored to the bone. Keel features 2 delta-shaped wings. Central part is

truncated cone-shaped to anchor tibial stems. Locking system for tibial insert - step to be coupled to

flexible clips located in the anterior part of tibial insert; posterior part, stair to be coupled with a groove

located at the base of tibial insert avoids detachment of components.

Intended purpose

A tibial component of a tricompartmental fixed-bearing prosthesis to be used in PCL (Posterior Cruciate

Ligament) retaining/sacrificing TKR (Total Knee Replacement) for primary and revision surgery. Main

indications:

- Primary and secondary arthrosis

- Rheumatoid arthritis

- Bone necrosis

- Revisions, where other devices or treatments have failed

Variant information

Size 1-7

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 03.11.2017 at 11:22:30 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

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