PROSTHESIS

Main information

  • Trade name:
  • PROSTHESIS Fracture Head (CoCrMo) - Metallic femoral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • PROSTHESIS Fracture Head (CoCrMo) - Metallic femoral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220353
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220353

Smith & Nephew Pty Ltdy Ltd - PROSTHESIS Fracture Head (CoCrMo) - Metallic femoral head prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

21/02/2014

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

Smith & Nephew Orthopaedics AG

Oberneuhofstrasse 10d

Baar, , 6340

Switzerland

Products

1. PROSTHESIS Fracture Head (CoCrMo) - Metallic femoral head prosthesis

Product Type

Single Device Product

Effective date

21/02/2014

GMDN

33175 Metallic femoral head prosthesis

Functional description

A femoral head component that articulates against the acetabulum in hemiarthroplasty procedures. The

highly polished CoCrMo surface minimizes friction between the implant and acetabulum and the standard

12/14 taper allows for various stem options. Following femoral head removal, the femoral canal is

prepared and the femoral component is implanted. The fracture head is permanently fixed onto the femoral

component with a plastic hammer following trial reduction.

Intended purpose

A sterile femoral head component of a partial hip system. The fracture head is intended to be used for the

following indications:

·Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.

·Fracture or avascular necrosis of the femoral head

·Conditions resulting from previous operations, such as osseosynthesis, joint reconstruction, arthrodesis,

hemiarthroplasty or hip total prosthesis.

The Prosthesis Fracture Head is made from CoCrMo and should not be combined with stainless steel

stems.

Variant information

Size Small - Medium

Size 38M-60M

Size 38S-60S

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 04:24:59 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