Affinis

Main information

  • Trade name:
  • Affinis Fracture Stem Cemented - Prosthesis, internal, joint, shoulder, total
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Affinis Fracture Stem Cemented - Prosthesis, internal, joint, shoulder, total
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219731
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219731

Mathys Orthopaedics Pty Ltd - Affinis Fracture Stem Cemented - Prosthesis, internal, joint, shoulder, total

ARTG entry for

Medical Device Included Class III

Sponsor

Mathys Orthopaedics Pty Ltd

Postal Address

PO Box 671,LANE COVE, NSW, 1595

Australia

ARTG Start Date

30/01/2014

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

Mathys Ltd Bettlach

Robert Mathys Strasse 5 Bettlach

, , 2544

Switzerland

Products

1. Affinis Fracture Stem Cemented - Prosthesis, internal, joint, shoulder, total

Product Type

Single Device Product

Effective date

30/01/2014

GMDN

35670 Prosthesis, internal, joint, shoulder, total

Functional description

The Affinis Fracture Stem is manufactured from titanium alloy and is a cemented stem which is part of the

Affinis Fracture System that is designed for anatomical-biological healing. The fracture stem has a simple,

functional surgical strategy with primary cementing of the stem, without the use of trial prostheses.

Intended purpose

The Affinis Fracture Stem forms part of the Affinis Fracture Shoulder System that is designed for use in

multi-fragment and comminuted fractures of the humeral head, fractures of the proximal humerus that

cannot be treated with osteosynthesis, secondary fragment dislocation following osteosynthesis in the

proximal humerus in order to retain the joint function and in certain tumourrelated modifications of the

proximal humerus.

Variant information

Length (mm) 200mm

Diameter (mm) 6mm to 12mm

Length (mm) 125mm

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 06:48:08 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