PFC Sigma

Main information

  • Trade name:
  • PFC Sigma Cruciate Sacrificing Non Porous Femur - Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • PFC Sigma Cruciate Sacrificing Non Porous Femur - Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222054
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222054

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - PFC Sigma Cruciate Sacrificing Non Porous

Femur - Uncoated knee femur prosthesis

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

7/04/2014

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. PFC Sigma Cruciate Sacrificing Non Porous Femur - Uncoated knee femur prosthesis

Product Type

Single Device Product

Effective date

7/04/2014

GMDN

32831 Uncoated knee femur prosthesis

Functional description

The PFC Sigma cruciate sacrificing non porous femorals are a primary bicondylar replacement prosthesis

made of metal cobalt chrome, its implantation is performed with bone cement. It articulates with the tibial

insert of a knee joint prosthesis.

Intended purpose

The PFC Sigma Cruciate Sacrificing Non Porous Femurs are the femoral component used in total knee

arthroplasty and articulate with the insert component. It is intended to provide increased patient mobility

and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of

sufficient sound bone to seat and support the components. Candidates for total knee replacement include

patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post?traumatic

arthritis, rheumatoid arthritis, or a failed previous implant.

Variant information

Size 1.5 - 6

Size 4N

Shape Left and Right

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 02.12.2017 at 04:16:25 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