GMK Sphere Primary Femur TiNbN Coated Cemented - Coated knee femur prosthesis

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

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Available from:
Medacta Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
322278

Public Summary

Summary for ARTG Entry:

322278

Medacta Australia Pty Ltd - GMK Sphere Primary Femur TiNbN Coated Cemented - Coated knee femur

prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Medacta Australia Pty Ltd

Postal Address

Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

26/08/2019

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

Medacta International SA

Strada Regina 6874 Castel

, San Pietro,

Switzerland

Products

1. GMK Sphere Primary Femur TiNbN Coated Cemented - Coated knee femur prosthesis

Product Type

Single Device Product

Effective date

26/08/2019

GMDN

33745 Coated knee femur prosthesis

Functional description

The GMK Sphere Primary Femur is TiNbN Coated and is designed for cemented use in total knee

arthroplasty. The main purpose of the TiNbN coating is to limit the ion release from the underlying alloy.

The design of the GMK Sphere is characterized by a spherical medial femoral condyle and an

asymmetrical fixed tibial UHMWPE insert with a concave spherical medial compartment. This tibial-femoral

combination allows the medial "ball-in-socket" mechanism.

Intended purpose

Total Knee Prosthesis designed for tricompartmental replacement of the natural knee joint and intended to

provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is

evidence of sufficient sound bone to seat and support the components. Candidates for total knee

replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis,

post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure. If, in the opinion of the

surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age

of the patient, and if limited demands regarding activity and knee joint loading can be assured, total knee

replacement may be considered for young patients. This includes severely disabled patients with multiple

joint involvement for whom and immediate gain in knee mobility may lead to significant improvement of

their quality of life.

Variant information

Shape Left

Shape Right

Size 1 to 7

Specific Conditions

© 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 02.11.2019 at 06:00:43 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

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