OMNIFIT

Main information

  • Trade name:
  • OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated hip femur prosthesis, one-piece
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated hip femur prosthesis, one-piece
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216632
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216632

Stryker Australia Pty Ltd - OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated

hip femur prosthesis, one-piece

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

28/10/2013

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated hip femur prosthesis, one-piece

Product Type

Single Device Product

Effective date

28/10/2013

GMDN

34223 Uncoated hip femur prosthesis, one-piece

Functional description

A sterile implantable one piece Femoral Hip Stem designed to replace the proximal femoral neck as part of

a Hip Arthroplasty. Intraoperatively assembled with a Femoral Head with a C-taper or a C-taper extension

is required. Made of Cobalt Chrome and intended for use with cement.

Intended purpose

A component of a total hip joint prosthesis that is used to replace the femoral neck.

For use as a Bipolar Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the

femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular

involvement or distortion.

Other Considerations: Pathological conditions or age considerations which indicate a more conservative

acetabular procedure and an avoidance of the use of bone cement in the acetabulum. Salvage of failed

total hip arthroplasty.

For use as a Total Hip Replacement: Painful, disabling joint disease of the hip resulting from: degenerative

arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. Revision of previous

unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management

problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory

results.

Variant information

Size 4-13

Diameter (mm) Distal Stem 8.1 - 16.0

Length (mm) Stem 100 - 170

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 04:40:22 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