AGC V2 Total

Main information

  • Trade name:
  • AGC V2 Total Knee Anatomic Interlok Femoral Component - Cruciate-retaining total knee prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AGC V2 Total Knee Anatomic Interlok Femoral Component - Cruciate-retaining total knee prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217843
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217843

Zimmer Biomet Pty LtdPty Ltd - AGC V2 Total Knee Anatomic Interlok Femoral Component -

Cruciate-retaining total knee prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

28/11/2013

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

Biomet UK Ltd

Waterton Industrial Estate

Bridgend, South Glamorgan, CF31 3XA

Products

1. AGC V2 Total Knee Anatomic Interlok Femoral Component - Cruciate-retaining total knee prosthesis

Product Type

Single Device Product

Effective date

28/11/2013

GMDN

33664 Cruciate-retaining total knee prosthesis

Functional description

Chrome cobalt cruciate retaining femoral knee component with deep patella track, wide femoral condyles

Intended purpose

Chrome cobalt femoral component for cemented use in AGC V2 Total Knee arthroplasty; to provide a

means of reducing pain and restoring function. The indications for use include: Osteoarthritis, rheumatoid

arthritis; Traumatic arthritis;Failure of a previous joint replacement procedure; Correction of varus, valgus

or post-traumatic deformity; Correction or revision of unsuccessful osteotomy or arthrodesis.

Variant information

Size (mm) 55 to 80

Shape Right

Shape Left

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 12:48:53 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

21-11-2018

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22-7-2018

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Electronic submissions

Electronic submissions

Update of the eCTD document matrix v2.0 to v2.1 is effective from today

Therapeutic Goods Administration - Australia