SMR Adaptor

Main information

  • Trade name:
  • SMR Adaptor 36mm for Reverse Humeral Body Ti6AI4V - Humeral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • SMR Adaptor 36mm for Reverse Humeral Body Ti6AI4V - Humeral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221473
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221473

Lima Orthopaedics Australia Pty Ltd - SMR Adaptor 36mm for Reverse Humeral Body Ti6AI4V - 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

19/03/2014

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 Adaptor 36mm for Reverse Humeral Body Ti6AI4V - Humeral head prosthesis

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

48088 Humeral head prosthesis

Functional description

The SMR Adapter is inserted into the Reverse Humeral Body to accommodate the fitting of the Reverse

CTA Humeral Head. The CTA Humeral head articulates with the Reverse Glenosphere or replacement

Glenoid fossa prosthesis to provide movement within the shoulder joint.

Intended purpose

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder

replacement in a grossly rotator cuff deficient joint with severe arthropathy (disable shoulder). The SMR

Adaptor 36mm for Reverse Humeral Body is inserted into the SMR Reverse Humeral Body which is

attached to the humeral Stem. The intended purpose of the SMR Adaptor 36mm for Reverse Humeral

Body is to hold either the SMR Reverse Humeral Head or SMR Reverse CTA Humeral Head in place.

Variant information

Nil variant (as 1 device) Nil

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 12:56:37 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