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
© 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 02:39:31 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
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