Vanguard

Main information

  • Trade name:
  • Vanguard Knee DCM Anterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Vanguard Knee DCM Anterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219841
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219841

Zimmer Pty Ltd - Vanguard Knee DCM Anterior Stabilised tibial bearing - Prosthesis, knee, internal, insert

component

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

4/02/2014

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 Knee DCM Anterior Stabilised tibial bearing - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

4/02/2014

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

The tibial bearing is constructed of direct compression moulded Arcom UHMWPE and articulates with the

femoral and tibial tray components in patients with intact posterior cruciate ligaments. The AS bearing

presents an ultra congruent deep dish design with 6 degrees internal/external rotation.

Intended purpose

The Vanguard anterior stabilised UHMWPE tibial bearing is designed for use in treatment of low demand,

less active or sedentary patients, with intact cruciate ligament, as one component of the Vanguard total

knee system. The indications for use:

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

where one or more compartments are involved.

2. Correction of varus, valgus or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement

procedure

Variant information

Size (mm) 63 to 83

Size (mm) 10 to 20

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 06:23:35 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