Summary for ARTG Entry:
Tornier Pty Ltd - Simpliciti Nucleus - Coated shoulder humeral stem prosthesis
ARTG entry for
Medical Device Included Class III
Tornier Pty Ltd
PO Box 230,BELROSE, NSW, 2085
ARTG Start Date
Medical Device Class III
- 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.
7701 France Avenue S Suite 600
Edina, MN, 55435
United States Of America
1. Simpliciti Nucleus - Coated shoulder humeral stem prosthesis
Single Device Product
39702 Coated shoulder humeral stem prosthesis
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 for total and hemi-arthroplasty of the shoulder.
Size 1 - 3
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.
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Produced at 09.11.2017 at 08:39:28 AEDT
This is not an ARTG Certificate document.
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