Active

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

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Public Summary

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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.

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