Reclaim

Main information

  • Trade name:
  • Reclaim Conical Proximal Body - Press-fit hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Reclaim Conical Proximal Body - Press-fit hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219085
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219085

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Reclaim Conical Proximal Body - Press-fit hip

femur prosthesis, modular

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

10/01/2014

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

Depuy (Ireland)

Loughbeg Ringaskiddy

COUNTY CORK, ,

Ireland

Products

1. Reclaim Conical Proximal Body - Press-fit hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

10/01/2014

GMDN

55833 Press-fit hip femur prosthesis, modular

Functional description

The Reclaim Conical Promixal Body is made from Titanium and is coated allowing for cementless fixation.

Using a locking bolt for additional fixation, the Reclaim Conical Promixal Body press-fits onto the Reclaim

Distal Stem and a femoral head press fits onto the neck.

Intended purpose

The Reclaim Conical Proximal Body is the proximal body component of the Reclaim Revision Hip System

which 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. The Reclaim Revision Hip System is indicated for cementless use in the treatment of failed

previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface

replacement arthroplasty, or other total hip replacement.

Variant information

Offset 40mm and 45mm

Height (mm) 75-105

Diameter (mm) 20-28

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 04:40:46 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