RESTORATION

Main information

  • Trade name:
  • RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217755
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217755

Stryker Australia Pty Ltd - RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

26/11/2013

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension

Product Type

Single Device Product

Effective date

26/11/2013

GMDN

33714 Body femoral extension

Functional description

A sterile distal extension stem designed to connect intraoperatively with a Restoration Modular Femoral

Body. When connected together they are designed to replace the proximal femoral neck. Further it is

intended to be assembled Intraoperatively with a Femoral Head. Made of Titanium Alloy and intended to

be pressfit into the bone without the use of cement.

Intended purpose

The RESTORATION Modular Hip System is intended for primary and revision total hip arthroplasty as well

as in the presence of severe bone loss. These femoral stems are designed to be press fit into the proximal

femur. Indications:

· Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

· Rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup);

· Correction of functional deformity;

· Revision procedures where other treatments or devices have failed; and,

· Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head

involvement that are unmanageable using other techniques.

Variant information

Diameter (mm) 11 - 26

Length (mm) 127 - 317

Shape Straight

Shape Bowed

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 01:08:26 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.

Visit www.tga.gov.au for contact information

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