Simpliciti

Main information

  • Trade name:
  • Simpliciti Nucleus - Coated shoulder humeral stem prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Simpliciti Nucleus - Coated shoulder humeral stem prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222657
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222657

Tornier Pty Ltd - Simpliciti Nucleus - Coated shoulder humeral stem prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085

Australia

ARTG Start Date

17/04/2014

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

Tornier Inc

7701 France Avenue S Suite 600

Edina, MN, 55435

United States Of America

Products

1. Simpliciti Nucleus - Coated shoulder humeral stem prosthesis

Product Type

Single Device Product

Effective date

17/04/2014

GMDN

39702 Coated shoulder humeral stem prosthesis

Functional description

The metaphyseal humeral component of a total shoulder or hemi-shoulder prosthesis. It is used as part of

a system that also includes a metal humeral head and (for total shoulder) an ultrahigh molecular weight

polyethylene glenoid component.

It is made of titanium alloy with a sintered bead coating that allows for bone in-growth. It is intended for

press-fit un-cemented use.

Intended purpose

Intended for total and hemi-arthroplasty of the shoulder.

Variant information

Size 1 - 3

Specific Conditions

The sponsor must provide to the TGA results of the USA Investigational Device Exemption (IDE) clinical study that is conducted in relation to the kind of

device included under this ARTG entry and clinical evaluation report on the study . This information must be provided to the Office of Product Review of

the Therapeutic Goods Administration (TGA) at the completion of the abovementioned clinical study specifically, after the 24 month appointments for all

patients in the study have completed and collation of the data has been concluded.

© 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 09.11.2017 at 08:39:28 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