Main information

  • Trade name:
  • PROFIX Non-Porous Tibial Base - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • PROFIX Non-Porous Tibial Base - Uncoated knee tibia prosthesis, metallic
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220596
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Smith & Nephew Pty Ltdy Ltd - PROFIX Non-Porous Tibial Base - Uncoated knee tibia prosthesis, metallic

ARTG entry for

Medical Device Included Class III


Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Smith & Nephew Inc Orthopaedic Division

1450 E Brooks Road

Memphis, TN, 38116

United States Of America


1. PROFIX Non-Porous Tibial Base - Uncoated knee tibia prosthesis, metallic

Product Type

Single Device Product

Effective date



32832 Uncoated knee tibia prosthesis, metallic

Functional description

A non-porous tibial component with horizontal cement grooves and a grit-blasted surface. Following

resection of the tibia, trialing and then punching with the Nonporous Tibial Fin Punch, the tibial implant

undersurface is coated with bone cement and positioned using the Tibial Rotation Alignment Guide and

impacted onto the proximal tibia using the tibial impactor. After insert thickness is determined, the insert is

placed onto the tibial implant and the peripheral locking mechanism is engaged.

Intended purpose

A sterile tibial base component of a total knee system. PROFIX Non-Porous Tibial Base components are

indicated for the following conditions: rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or

degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

Variant information

Width (mm) 42-61

Length (mm) 61-91

Shape Left and Right

Size 1-7

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 03:39:45 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.

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