Biomet

Main information

  • Trade name:
  • Biomet Series A Patella three peg - Polyethylene patella prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Biomet Series A Patella three peg - Polyethylene patella prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219858
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219858

Zimmer Biomet Pty Ltd - Biomet Series A Patella three peg - Polyethylene patella 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

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. Biomet Series A Patella three peg - Polyethylene patella prosthesis

Product Type

Single Device Product

Effective date

4/02/2014

GMDN

34199 Polyethylene patella prosthesis

Functional description

Arcom UHMWPE domed patella implant with three pegs. Available in standard or thin profile, for use with

femoral implant; intended for cemented use.

Intended purpose

Polyethylene patella component for use during knee arthroplasty to repair the patella bearing surface.

Device is intended for cemented use and is made of Arcom UHMWPE.

The indications for use: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis

and/or 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.

Variant information

Thickness Thin 6.2-8.5MM

Thickness Standard 8-10MM

Diameter (mm) 25-40

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 06:20:01 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