Solution

Main information

  • Trade name:
  • Solution Femoral Stems - Coated femoral stem prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Solution Femoral Stems - Coated femoral stem prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222149
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222149

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Solution Femoral Stems - Coated femoral stem

prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

8/04/2014

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

Depuy Orthopaedics Inc

700 Orthopaedic Drive

Warsaw, IN, 46582

United States Of America

Products

1. Solution Femoral Stems - Coated femoral stem prosthesis, modular

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

34191 Coated femoral stem prosthesis, modular

Functional description

Solution Femoral Stems are made from CoCr and have a 12/14 taper to accept a 12/14 tapered femoral

head. They are indicated for cementless use with fixation provided by biological tissue ingrowth into the

Porocoat coating.

Intended purpose

The Solution Femoral Stem is the femoral component in revision total hip arthroplasty which is intended to

provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in

patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,rheumatoid arthritis, or

congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty,

surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Variant information

Size 6" - 10"

Shape Bowed

Shape Straight

Shape Left or Right

Size (mm) 10.5 - 22.5

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 02.12.2017 at 04:15:34 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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