NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit - Rotating hinged total knee prosthesis

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

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Available from:
Zimmer Biomet Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
293755

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Public Summary

Summary for ARTG Entry:

293755

Zimmer Biomet Pty Ltd - NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service

Kit - Rotating hinged total knee prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

12/09/2017

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

Zimmer Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit - Rotating hinged total

knee prosthesis

Product Type

Single Device Product

Effective date

12/09/2017

GMDN

33692 Rotating hinged total knee prosthesis

Functional description

The NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit is comprised of

the NexGen Rotating Hinge Knee polyethylene box insert, one-piece hinge post, CoCrMo hinge pin, hinge

pin plug and tibial bushing. It is designed to allow the replacement or servicing of the NexGen Rotating

Hinge Knee Articular Surface or Segmental Articular Surface and the modular hinge post in situ without

disrupting the fixation of the femoral and tibial components.

Intended purpose

The NexGen Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit is a component of

the NexGen® Rotating Hinge Knee (RH Knee) which is designed for revision, difficult primary, and limb

salvage surgeries in patients with significant bone loss and/or ligament deficiencies.

Indicated for patients with:

± Moderate to severe knee instability.

± Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis,

osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral

condyle.

± Valgus, varus, or flexion deformities.

± The salvage of previously failed surgical attempts.

Variant information

Size B-F

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 03:26:24 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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