Main information

  • Trade name:
  • ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217739
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Stryker Australia Pty Ltd - ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece

ARTG entry for

Medical Device Included Class III


Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570


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.




Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America


1. ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece

Product Type

Single Device Product

Effective date



55834 Press-fit hip femur prosthesis, one-piece

Functional description

A sterile implantable one piece Femoral Hip Stem designed to replace the proximal femoral neck as part of

a Hip Arthroplasty (Available 127 Degree Neck Angle). A circumferential titanium plasma spray surface

over the proximal body assists with mechanical engagement in bone. Intraoperatively assembled with a

Femoral Head. Made of Cobalt Chrome and intended for use without cement.

Intended purpose

A component of a total hip joint prosthesis that is used to replace the femoral neck. The indications for use

for total hip and hemi hip arthroplasty include:

1. non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. rheumatoid arthritis;

3. correction of functional deformity;

4. revision procedures where other treatments or devices have failed; and,

5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head

involvement that are unmanageable using other techniques.

Variant information

Offset 38mm - 54mm

Length (mm) Stem 110mm - 145mm

Length (mm) Neck 30mm - 40mm

Size 1 - 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

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:11:43 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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