Affinis

Main information

  • Trade name:
  • Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219396
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219396

Mathys Orthopaedics Pty Ltd - Affinis Stem Cemented - Uncoated shoulder humeral stem 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

20/01/2014

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 AG

5 Robert Mathys Strasse

Bettlach, , 2544

Switzerland

Products

1. Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis

Product Type

Single Device Product

Effective date

20/01/2014

GMDN

34197 Uncoated shoulder humeral stem prosthesis

Functional description

The Affinis cemented stem has grooves to ensure safe anchoring in the cement coating, and 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 cemented stem 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) 6mm to 15mm

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 07:43:07 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