Wagner

Main information

  • Trade name:
  • Wagner Cone Prosthesis™ Hip Stem - Press-fit hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Wagner Cone Prosthesis™ Hip Stem - Press-fit hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216270
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216270

Zimmer Pty Ltd - Wagner Cone Prosthesis™ Hip Stem - Press-fit hip femur prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

21/10/2013

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

Zimmer GmbH

Sulzer Allee 8

, Winterthur, CH-8404

Switzerland

Products

1. Wagner Cone Prosthesis™ Hip Stem - Press-fit hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

55833 Press-fit hip femur prosthesis, modular

Functional description

A femoral stem component used in conjunction with a femoral head component for replacement of the

proximal femur in total hip arthroplasty. It is manufactured from Titanium alloy (Protasul®-64) Alloy with a

rough blasted surface to stimulate osseointegration.

Intended purpose

The femoral stem component is used in conjunction with a femoral head component for replacement of the

proximal femur in total hip arthroplasty for:

-Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and

inflammatory joint disease (IJD), e.g. rheumatoid arthritis.

-Failed previous surgery where pain, deformity, or dysfunction persists.

-Revision of previously failed hip arthroplasty.

Variant information

Size (mm) 13-24

Angle (In degrees) 125-135

Length (mm) 115-127.6

Offset 26.2 - 40.0

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 05:29:28 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