SMR Cemented

Main information

  • Trade name:
  • SMR Cemented Humeral Stem Ti6Al4V - Uncoated shoulder humeral stem prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • SMR Cemented Humeral Stem Ti6Al4V - Uncoated shoulder humeral stem prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218715
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218715

Lima Orthopaedics Australia Pty Ltd - SMR Cemented Humeral Stem Ti6Al4V - Uncoated shoulder humeral

stem prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Lima Orthopaedics Australia Pty Ltd

Postal Address

Unit 1 40 Ricketts Road,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

20/12/2013

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

Limacorporate Spa

Via Nazionale 52

Villanova San Daniele del Friuli, Udine, 33038

Italy

Products

1. SMR Cemented Humeral Stem Ti6Al4V - Uncoated shoulder humeral stem prosthesis

Product Type

Single Device Product

Effective date

20/12/2013

GMDN

34197 Uncoated shoulder humeral stem prosthesis

Functional description

A cemented stem made of Ti6Al4V that is position in the humerus and can be fitted with a humeral body

that can be attached to a humeral head or a reverse humeral body that can be fitted with a liner to provide

an articulation surface within the replacement shoulder joint.

Intended purpose

The SMR Humeral Stems are part of the SMR Shoulder System which is intended for partial, total, Primary

or Revision shoulder joint replacement when suffering from disability due to, non-inflammatory

degenerative joint disease including osteoarthritis and avascular necrosis, inflammatory degenerative joint

disease such as rheumatoid arthritis, treatment of acute fractures of the humeral head that cannot be

treated with other fracture fixation methods and revision of a failed primary implant.

Variant information

Length (mm) 80

Diameter (mm) 12 to 20

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 09:34:53 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