Affimis

Main information

  • Trade name:
  • Affimis CoCr Head - Humeral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Affimis CoCr Head - Humeral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220762
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220762

Mathys Orthopaedics Pty Ltd - Affimis CoCr Head - Humeral head prosthesis

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

6/03/2014

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. Affimis CoCr Head - Humeral head prosthesis

Product Type

Single Device Product

Effective date

6/03/2014

GMDN

48088 Humeral head prosthesis

Functional description

The Affinis CoCr head provides an adjustable posterior offset with an eccentric head trunnion. The head

forms part of the Affinis Total Shoulder Prosthesis which offers precise adjustability to the existing anatomy

to restore the center of rotation and exact reconstruction of the proximal humerus.

Intended purpose

The Affinis cobalt chrome head forms part of the Affinis Total Shoulder System that is designed for treating

shoulder conditions such as Primary Osteoarthritis, Secondary Osteoarthritis, Rheumatoid Arthritis,

Post-traumatic Osteoarthritis, Cuff Tear Arthropathy (Hamada grade III or IV) in younger patients,

Metabolic joint destruction (e.g. chondrocalcinosis, haemo- siderosis, urate arthropathy)), fracture

sequelae (malformation healing of humeral head fractures, non union healing/ pseudarthrosis, head

necrosis, locked dislocations) and avascular head necrosis.

Variant information

Diameter (mm) 39mm to 53mm

Height (mm) 13mm to 20mm

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 03:12:44 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