SMR Adaptor

Main information

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



  • Available in:
  • SMR Adaptor Taper - Humeral head prosthesis
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221712
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Lima Orthopaedics Australia Pty Ltd - SMR Adaptor Taper - Humeral head prosthesis

ARTG entry for

Medical Device Included Class III


Lima Orthopaedics Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Limacorporate Spa

Via Nazionale 52

Villanova San Daniele del Friuli, Udine, 33038



1. SMR Adaptor Taper - Humeral head prosthesis

Product Type

Single Device Product

Effective date



48088 Humeral head prosthesis

Functional description

The SMR adaptor is made of Ti6Al4V and is designed to be inserted into the Humeral Head and is

attached to the humeral body. The Humeral head articulates with the natural glenoid fossa or a

replacement glenoid fossa prosthesis to provide movement within the shoulder joint.

Intended purpose

The SMR Humeral Head adaptor 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

Size Standard to Long

Offset 0 to +8

Shape Neutral and 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

Public Summary

Page 1 of

Produced at 10.11.2017 at 12:09:26 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.

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