Tri-Lock

Main information

  • Trade name:
  • Tri-Lock BPS Femoral Stem - Tri-Lock BPS Femoral Stem - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tri-Lock BPS Femoral Stem - Tri-Lock BPS Femoral Stem - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217546
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217546

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Tri-Lock BPS Femoral Stem - Coated 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

20/11/2013

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

Depuy Orthopaedics Inc

700 Orthopaedic Drive

Warsaw, IN, 46582

United States Of America

Products

1. Tri-Lock BPS Femoral Stem - Tri-Lock BPS Femoral Stem - Coated hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

20/11/2013

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

The Tri-Lock BPS Femoral Stem is a modular titanium/aluminium alloy stem with a porous coating

(Gription) to allow biological fixation. Tri-Lock BPS Femoral Stem is indicated for cementless use. The

12/14 tape of the Tri-Lock BPS Femoral Stem accepts a corresponding 12/14 taper head.

Intended purpose

The Tri-Lock BPS Femoral Stem is one component of a total or hemi hip arthroplasty and 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.

Additionally, for hemi hip arthroplasty, where there is evidence of a satisfactory natural acetabulum and

sufficient femoral bone to seat and support the femoral stem.

Variant information

Offset HI or STD

Size 0-12

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 04:54:33 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

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