Modular

Main information

  • Trade name:
  • Modular Dual Mobility (MDM) LINER - Metallic acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Modular Dual Mobility (MDM) LINER - Metallic acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217674
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217674

Stryker Australia Pty Ltd - Modular Dual Mobility (MDM) LINER - Metallic acetabular liner

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

22/11/2013

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. Modular Dual Mobility (MDM) LINER - Metallic acetabular liner

Product Type

Single Device Product

Effective date

22/11/2013

GMDN

48056 Metallic acetabular liner

Functional description

This Acetabular Liner is the middle portion of an artificial three-piece acetabular component that is sterile

and made of Cobalt Chrome. This device is inserted into an Acetabular Shell and articulates with a

corresponding Acetabular Insert. The Acetabular Insert further articulates with an artificial Femoral Head

as part of a Total Hip Arthroplasty (THA). Facilitates a Trident locking mechanism, this will allow for

compatibility with an Acetabular Shell containing the same locking mechanism.

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum.

The indications for use for total 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.

6. Dislocation risks

RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.

Variant information

Diameter (mm) Outer 36mm - 58mm

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 01:27:48 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