Taperloc

Main information

  • Trade name:
  • Taperloc Primary Porous and Hydroxyapatite Coated Type 1 Taper Femoral Stem - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Taperloc Primary Porous and Hydroxyapatite Coated Type 1 Taper Femoral Stem - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222180
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222180

Zimmer Pty Ltd - Taperloc Primary Porous and Hydroxyapatite Coated Type 1 Taper Femoral Stem -

Coated hip femur prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

8/04/2014

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

Biomet UK Ltd

Waterton Industrial Estate

Bridgend, South Glamorgan, CF31 3XA

Products

1. Taperloc Primary Porous and Hydroxyapatite Coated Type 1 Taper Femoral Stem - Coated hip femur

prosthesis, modular

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

Porous and hydroxyapatite coated titanium alloy femoral stem with type 1 taper and flat tapered wedge

geometry to provide bone preservation, rotational stability and enhanced proximal offloading. Standard

and lateralized offset options are available for various patient anatomies. PPS coating allows for initial

scratch-fit stability and bone in-growth; 5 micrometer HA coating retains PPS topography.

Intended purpose

Taperloc femoral stem prosthesis for use in primary and revision hemi or total hip arthroplasty. Indications

for use include non-inflammatory degenerative joint diseases including osteoarthritis, avascular necrosis;

rheumatoid arthritis; correction of functional deformities; treatment of non-union, femoral neck and

trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable

using other techniques; reviiosn procedures where other treatment or devices have failed. Stem is

constructed of porous and hydroxyapatite coated titanium alloy and is intended for uncemented biological

fixation.

Variant information

Offset Lateralised

Diameter (mm) 6-20

Length (mm) 132-160

Offset Standard

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 09.11.2017 at 10:30:57 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