DeltaMotion

Main information

  • Trade name:
  • DeltaMotion Modular Sleeve - Ceramic femoral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • DeltaMotion Modular Sleeve - Ceramic femoral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218643
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218643

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - DeltaMotion Modular Sleeve - Ceramic femoral

head prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

18/12/2013

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

Depuy (Ireland)

Loughbeg Ringaskiddy

COUNTY CORK, ,

Ireland

Products

1. DeltaMotion Modular Sleeve - Ceramic femoral head prosthesis

Product Type

Single Device Product

Effective date

18/12/2013

GMDN

38156 Ceramic femoral head prosthesis

Functional description

DeltaMotion Modular Sleeves are a range of Titanium alloy sleeves for use with DeltaMotion

Modular Heads and which connect the heads to a suitable femoral stem. The sleeves are provided in

a range of sizes/offsets to allow some variation of the femoral neck length.

Intended purpose

The DeltaMotion Modular Sleeves, when used in combination with a DeltaMotion Modular Ceramic head

during total hip arthroplasty, is intended to provide increased patient mobility and reduce pain by replacing

the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and

support the components.

Variant information

Size XL

Size S

Size M

Size L

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 02.12.2017 at 04:44:23 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