PFC Sigma

Main information

  • Trade name:
  • PFC Sigma Modular Plus Tibial Tray - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • PFC Sigma Modular Plus Tibial Tray - Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221774
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221774

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - PFC Sigma Modular Plus Tibial Tray - Uncoated

knee tibia prosthesis, metallic

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

28/03/2014

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 Modular Plus Tibial Tray - Uncoated knee tibia prosthesis, metallic

Product Type

Single Device Product

Effective date

28/03/2014

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

The PFC Sigma Modular Plus Tibial Tray is made of a titanium alloy and is intended for cemented use

during revision or primary total knee arthroplasty. The modular stem attachment of the offset variant is

offset medially from the centre of the plateau which provides optimal proximal tibial plateau coverage while

also facilitating proper stem placement in the intramedullary canal.

Intended purpose

The PFC Sigma Modular Plus Tibial Tray is the tibial component which holds the insert component of a

total knee arthroplasty. 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, posttraumatic arthritis, rheumatoid

arthritis, or a failed previous implant.

Variant information

Offset Offset Tibial Tray LM/RL and RM/LL

Product name (see guidance docs) PFC Sigma

Modular Plus Tibial Tray

Product name (see guidance docs) PFC Sigma

Modular Plus Offset Tibial Tray

Size 1.5 - 5

Offset Offset Tibial Tray Left and Right

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 04:18:22 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