Vanguard

Main information

  • Trade name:
  • Vanguard SSK DCM non-constrained small post tibial bearing - Prosthesis, internal, joint, knee, tot - Posterior-stabilized total
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Vanguard SSK DCM non-constrained small post tibial bearing - Prosthesis, internal, joint, knee, tot - Posterior-stabilized total
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221507
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221507

Zimmer Pty Ltd - Vanguard SSK DCM non-constrained small post tibial bearing - Posterior-stabilized 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

20/03/2014

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 Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Vanguard SSK DCM non-constrained small post tibial bearing - Prosthesis, internal, joint, knee, tot -

Posterior-stabilized total knee prosthesis

Product Type

Single Device Product

Effective date

20/03/2014

GMDN

33665 Posterior-stabilized total knee prosthesis

Functional description

The Vanguard SSK DCM non-constrained small post tibial bearing is constructed of direct compression

moulded Arcom UHMWPE and articulates with the femoral and tibial tray components of the Vanguard

Super Stabilized Knee system. The device has a swept back tibial post and deep anterior cutout.

Intended purpose

The Vanguard SSK Direct Compression Moulded Arcom UHMWPE non-constrained small post tibial

bearing is intended for use in treatment of low demand, less active or sedentary patients, as one

component of the Vanguard SSK total knee system. Indications for use for this knee system are:

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where

one or more compartments are involved; correction of varus, valgus, or posttraumatic deformity; correction

or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The

system is intended for application with or without cement in both primary and revision applications.

Variant information

Size (mm) 59-75

Size (mm) 10-24

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 12:50:03 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