Main information

  • Trade name:
  • Exacta Femoral Stem HX-Pore - Press-fit hip femur prosthesis, one-piece
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Exacta Femoral Stem HX-Pore - Press-fit hip femur prosthesis, one-piece
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220150
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Mac Surgical - Exacta Femoral Stem HX-Pore - Press-fit hip femur prosthesis, one-piece

ARTG entry for

Medical Device Included Class III


Mac Surgical

Postal Address

6 Roger Street,BROOKVALE, NSW, 2100


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.




Permedica SPA

23807 Merate (LC)

Via Como 38, ,



1. Exacta Femoral Stem HX-Pore - Press-fit hip femur prosthesis, one-piece

Product Type

Single Device Product

Effective date



55834 Press-fit hip femur prosthesis, one-piece

Functional description

The Exacta HX-Pore Stem is a press-fit stem with pure titanium and hydroxyapatite coating. It is a self

locking stem with longitudinal and transverse grooves on the anterior and posterior surface to provide axial

and rotational stability.

Intended purpose

The Exacta HX-Pore femoral stem is indicated for avascular necrosis of the femoral head, fractures of the

femoral neck/head, rheumatoid arthritis, primary/secondary arthrosis, post-traumatic arthrosis, collagen

disease, dysplasia and congenital dislocation of the hip and epiphysiolysis.

Variant information

Angle (In degrees) 135 degrees

Angle (In degrees) 127 degrees

Size 1 to 8

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 05:07:01 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