Biomet

Main information

  • Trade name:
  • Biomet Primary Tibial Interlok Plate - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Biomet Primary Tibial Interlok Plate - Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221509
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221509

Zimmer Biomet Pty Ltd - Biomet Primary Tibial Interlok Plate - Uncoated knee tibia prosthesis, metallic

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

20/03/2014

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 Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Biomet Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Biomet Primary Tibial Interlok Plate - Uncoated knee tibia prosthesis, metallic

Product Type

Single Device Product

Effective date

20/03/2014

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

Titanium alloy Interlok finish tibial tray. Nine sizes utilize available tibial plateau bone, offering uniform

distribution of tibio-femoral forces. Various stem options may be selected intra-operatively. Combination of

Morse taper and screw fixation creates sold cold weld between stem and plate. Packaged with slide-in

locking bar that provides compressive polyethylene locking mechanism

Intended purpose

Titanium alloy tibial plate with Interlok finish. Intended for cemented use as one component of a total knee

joint replacement prosthesis. Indications for use: Painful and disabled joint resulting from osteoarthritis,

rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; Correction of

valgus, varus, or post-traumatic deformity; Correction or revision of unsuccessful osteotomy, arthrodesis,

or failure of previous joint replacement procedure.

Variant information

Size (mm) 59-91

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 12:49:31 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