Aesculap Patella 3-Pegs - Cruciate-retaining total knee prosthesis

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
B Braun Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
293939

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Public Summary

Summary for ARTG Entry:

293939

B Braun Australia Pty Ltd - Aesculap Patella 3-Pegs - Cruciate-retaining total knee prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

15/09/2017

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

Aesculap AG

AM Aesculap Platz

Tuttlingen, , D-78532

Germany

Products

1. Aesculap Patella 3-Pegs - Cruciate-retaining total knee prosthesis

Product Type

Single Device Product

Effective date

15/09/2017

GMDN

33664 Cruciate-retaining total knee prosthesis

Functional description

The Universal Patella is used to resurface the Patella in either primary or revision total knee arthroplasty

and is compatible with the implant systems Vega, e.motion, Columbus and EnduRo. The rear of the patella

implant has 3 pegs for fixation in the bone. Cement pockets on the under surface of the patella guarantee

the minimum thickness of the cement mantle. The Patella implants are made out of UHMWPE and include

X-Ray markers made out of Stainless steel.

Intended purpose

The implant is used as a component part of a human knee endoprosthesis in combination with Aesculap

knee endoprosthetic components. Indicated for use in severe knee joint conditions that cannot be treated

through other therapies:

· Degenerative osteoarthritis

· Rheumatoid arthritis

· Posttraumatic arthritis

· Symptomatic knee instability

· Knee stiffness

· Deformation of the knee joint

The surgeon can select the optimum solution for the patient from the various implant types of the knee

systems, according to the severity of the condition. The surgeon is responsible for correctly establishing

the indication.

Variant information

Size (mm) 26 x 7

Size (mm) 29 x 8

Size (mm) 32 x 9

Size (mm) 35 x 10

Size (mm) 38 x 11

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 22.11.2017 at 09:36:10 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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