Biomet

Main information

  • Trade name:
  • Biomet Suture Patella Button single peg with wire - Polyethylene patella prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Biomet Suture Patella Button single peg with wire - Polyethylene patella prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220352
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220352

Zimmer Biomet Pty Ltd - Biomet Suture Patella Button single peg with wire - 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

21/02/2014

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 Suture Patella Button single peg with wire - Polyethylene patella prosthesis

Product Type

Single Device Product

Effective date

21/02/2014

GMDN

34199 Polyethylene patella prosthesis

Functional description

Arcom UHMWPE/stainless steel patellar component with single 1/4 inch peg and stainless steel wire.

Designed for use with bone cement and sutures.

Intended purpose

Patella component for use during knee arthroplasty to repair the patella bearing surface. Device is

intended for cemented use with sutures. Indications for use: 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.

Variant information

Size (mm) 28 to 37

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 04:25:14 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