Endo-Model

Main information

  • Trade name:
  • Endo-Model Rotational Knee Joint Prosthesis cementable with anti-luxation and patella flange - Prosthesis, internal, joint, knee
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Endo-Model Rotational Knee Joint Prosthesis cementable with anti-luxation and patella flange - Prosthesis, internal, joint, knee
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221853
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221853

Link Orthopaedics Australia Pty Ltd - Endo-Model Rotational Knee Joint Prosthesis cementable with

anti-luxation and patella flange - Rotating hinged total knee prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Link Orthopaedics Australia Pty Ltd

Postal Address

7/ 84 Poinciana Avenue,Tewantin, QLD, 4565

Australia

ARTG Start Date

1/04/2014

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

Waldemar Link GmbH & Co

Barkhausenweg 10

Hamburg, , 22339

Germany

Products

1. Endo-Model Rotational Knee Joint Prosthesis cementable with anti-luxation and patella flange - Prosthesis,

internal, joint, knee, tot - Rotating hinged total knee prosthesis

Product Type

Single Device Product

Effective date

1/04/2014

GMDN

33692 Rotating hinged total knee prosthesis

Functional description

Endo-Model Rotational Knee Joint Prosthesis with Patella flange already assembled allows axial rotation,

reduces the forces acting on the prosthesis anchorage and allows flexion up to 165 degrees, flange for

use when replacing the patellofemoral joint and for revisions, and cementable with anti-fluxation, made

from CoCrMo and UHMWPE

Intended purpose

Endo-Model Rotational Knee Joint Prosthesis with Patellar is intended for use in severely restricted joint

mobility due to degenerative, rheumatoid or post-traumatic arthritis or osteoarthritis; joint factures that

preclude osteosynthesis

·Bone necroses

·Bicondylar arthritis with insufficient colateral ligaments

·Revision surgery after hinge knee or rotational prosthesis

·Revision surgery with insufficient bone quality

Variant information

Size small

Size medium

Size large

Size medium extra long femoral stem

Shape Right

Shape Left

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 09.11.2017 at 11:35:23 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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