PROFEMUR

Main information

  • Trade name:
  • PROFEMUR® L Classic Hip HA Coated - Press-fit hip femur prosthesis, one-piece
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • PROFEMUR® L Classic Hip HA Coated - Press-fit hip femur prosthesis, one-piece
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218787
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218787

MicroPort Orthopedics Pty Ltd- PROFEMUR® L Classic Hip HA Coated - Press-fit hip femur prosthesis,

one-piece

ARTG entry for

Medical Device Included Class III

Sponsor

MicroPort Orthopedics Pty Ltd

Postal Address

PO Box 6052,Frenchs Forest, NSW, 1640

Australia

ARTG Start Date

23/12/2013

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

MicroPort Orthopedics Inc

5677 Airline Road

Arlington, TN, 38002

United States Of America

Products

1. PROFEMUR® L Classic Hip HA Coated - Press-fit hip femur prosthesis, one-piece

Product Type

Single Device Product

Effective date

23/12/2013

GMDN

55834 Press-fit hip femur prosthesis, one-piece

Functional description

This fixed neck femoral stem has a rectangular cross-section and longitudinal grooves distally. Proximally,

the stem has a trapezoidal cross-section and surface grooves perpendicular to stem longitudinal axis and

parallel with each other on anterior, posterior, and medial sides. It is offered in 11 sizes in either a standard

(neutral neck offset) or extended (8° varus neck offset) configuration to accommodate varying patient

anatomy.

Intended purpose

A total hip system component intended to replace the femur. Indications include use in total hip

arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the

following conditions:

1.non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis,

protrusio acetabuli, and painful hip dysplasia;

2.inflammatory degenerative joint disease such as rheumatoid arthritis;

3.correction of functional deformity; and,

4.revision procedures where other treatments or devices have failed.

Variant information

Offset Standard (Neutral)

Size 1-11

Offset Extended (8° Varus)

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 24.11.2017 at 02:13:12 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