Tibial

Main information

  • Trade name:
  • Tibial Implant - Stemmed Cemented - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tibial Implant - Stemmed Cemented - Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217127
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217127

Advanced Surgical Design & Manufacture Limited - Tibial Implant - Stemmed Cemented - Uncoated knee

tibia prosthesis, metallic

ARTG entry for

Medical Device Included Class III

Sponsor

Allegra Orthopaedics Limited

Postal Address

PO Box 72,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

12/11/2013

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

Allegra Orthopaedics Limited

Unit 2 / 12 Frederick Street

ST LEONARDS, NSW, 2065

Australia

Products

1. Tibial Implant - Stemmed Cemented - Uncoated knee tibia prosthesis, metallic

Product Type

Single Device Product

Effective date

12/11/2013

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

The stemmed tibial implant is symmetrical. The stemmed implants are manufactured from cast

cobalt-chrome-molybdenum (CoCrMo). The cemented tibial implant has a grit blast finish on the interior

surfaces.

Intended purpose

The stemmed tibial implant is a component of the Active Knee System. The patient should be skeletally

mature to receive a knee replacement. Patients should have adequate bone stock and size to support

prosthesis. It is intended for Non-inflammatory degenerative joint disease including osteoarthritis, traumatic

arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis;

Functional deformity such as varus, valgus or flexion deformities; Revision procedures where other

treatments or devices have failed; Fractures that are unmanageable using other techniques.

Variant information

Length (mm) 100-140

Size 1A-1B

Size 2A-2B

Size 3A-3B

Size 4A-4B

Size 5A-5B

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 03:17:44 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