AMIStem-H

Main information

  • Trade name:
  • AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218795
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218795

Medacta Australia Pty Ltd - AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece

ARTG entry for

Medical Device Included Class III

Sponsor

Medacta Australia Pty Ltd

Postal Address

Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

24/12/2013

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

Medacta International SA

Strada Regina 6874 Castel

, San Pietro, 0

Switzerland

Products

1. AMIStem-H Cementless Stem 12/14 - Press-fit femur prosthesis, one-piece

Product Type

Single Device Product

Effective date

24/12/2013

GMDN

55834 Press-fit hip femur prosthesis, one-piece

Functional description

The AMIStem-H has a triple tapered design that provides a good axial and rotational stability with optimal

anchoring to the bone, and the rectangular section allows excellent stability and preservation of bone

vascularisation. The horizontal and vertical macrostructures increase the stability and augment the contact

surface area by 10-15%. The double tapered distal tip reduces the risk of stress peak in the diaphysis.

Intended purpose

The AMIStem H hip prostheses are designed to be used in total or partial hip arthroplasty, for primary or

revision surgery.

Variant information

Shape Standard

Shape Lateralized

Size (mm) 00 to 9

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 23.11.2017 at 10:55:51 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