SMR Humeral

Main information

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

Documents

Localization

  • Available in:
  • SMR Humeral Head CoCrMo - Humeral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221715
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221715

Lima Orthopaedics Australia Pty Ltd - SMR Humeral Head CoCrMo - Humeral head 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

26/03/2014

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

Limacorporate Spa

Via Nazionale 52

Villanova San Daniele del Friuli, Udine, 33038

Italy

Products

1. SMR Humeral Head CoCrMo - Humeral head prosthesis

Product Type

Single Device Product

Effective date

26/03/2014

GMDN

48088 Humeral head prosthesis

Functional description

The Humeral Head is made of CoCrMo and is attached to the humeral body via a humeral head adaptor

and combined they provide articualtion in the shoulder joint with the natural glenoid fossa or a replacement

glenoid fossa prosthesis to provide movement.

Intended purpose

The SMR Humeral Head is part of the SMR Shoulder System which is intended for partial or total, primary

or revision shoulder joint replacement 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

Shape Standard or Flattened

Diameter (mm) 38 to 54

Offset 2 - 4 mm Eccentric

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 12:08:39 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