Meniscal

Main information

  • Trade name:
  • Meniscal Insert - Ultracongruent Plus - Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Meniscal Insert - Ultracongruent Plus - Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217305
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217305

Advanced Surgical Design & Manufacture Limited - Meniscal Insert - Ultracongruent Plus - Prosthesis,

knee, internal, insert component

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

14/11/2013

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. Meniscal Insert - Ultracongruent Plus - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

14/11/2013

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

A polyethylene liner component designed to provide the articulating bearing surface between the femoral

and tibial components of a total knee replacement. The Ultracongruent Plus is designed for use in patients

with an absent or severely deficient posterior cruciate ligament.

Intended purpose

The ultracongruent plus mensical insert 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

Size 1-5

Size 2N-5N

Thickness 6.0-17.5mm

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 02:39:46 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