Parva

Main information

  • Trade name:
  • Parva Cementless Stem - Press-fit hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Parva Cementless Stem - Press-fit hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220703
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220703

Adler Ortho Australia Pty Ltd - Parva Cementless Stem - Press-fit hip femur prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Adler Ortho Australia Pty Ltd

Postal Address

PO Box 1770,Capalaba, QLD, 4157

Australia

ARTG Start Date

5/03/2014

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

Adler Ortho Srl

9 Via dell'innovazione

Cormano, MI, 20032

Italy

Products

1. Parva Cementless Stem - Press-fit hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

5/03/2014

GMDN

55833 Press-fit hip femur prosthesis, modular

Functional description

The Parva Stem is made of titanium alloy and features the modular neck technology which is used to

optimise joint bio-mechanical joint reconstruction and stability. It has Ti-Por surface that maximises bone

in-growth after the primary mechanical fixation. For uncemented fixation and is designed to achieve

primary stability at the isthmic as well as intertrocanteric area.

Intended purpose

The Parva Stem is an uncemented stem that is designed to be used in hip arthroplasty for the following

indications: primary and secondary coxarthrosis, avascular and post-traumatic necrosis of the femoral

head, mild CDH cases and subcapital fractures of the Femoral head.

Variant information

Size 9 to 20

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 03:23:31 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