Active

Main information

Trade name:
Active Knee - Patella Implant - Polyethylene patella prosthesis

Available from:
Allegra Orthopaedics Limited

Class:
Class III

Medicine domain:
Humans

Medicine type:
Medical device

Documents

for the general public:
Public Assessment Report

for the general public:
The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.

Request the information leaflet for the general public.

for healthcare professionals:
The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.

Request the information leaflet for healthcare professionals.

Localization

Available in:
Australia

Language:
English

Other information

Status

Source:
Dept. of Health,Therapeutic Goods Administration - Australia

Authorization number:
217306

Last update:
09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217306

Advanced Surgical Design & Manufacture Limited - Active Knee - Patella Implant - Polyethylene patella

prosthesis

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. Active Knee - Patella Implant - Polyethylene patella prosthesis

Product Type

Single Device Product

Effective date

14/11/2013

GMDN

34199 Polyethylene patella prosthesis

Functional description

The patella component manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE) and has

a dome shape with the reverse curvature of the femoral condyles. The patella is designed for fixation with

PMMA - cement. The patella component is available in several sizes to suit different anatomies.

Intended purpose

The patella 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

Specific Conditions

No Specific Conditions included on Record

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 02:39:31 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

The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.

Request the information leaflet for the general public.
Documents in other languages are available here

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Active Knee - Patella Implant - Polyethylene patella prosthesis - english - Public Assessment Report

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