Comprehensive

Main information

  • Trade name:
  • Comprehensive Total Shoulder Humeral Fracture Stem with Macrobond - Prosthesis, internal, joint, shoulder, humeral component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Comprehensive Total Shoulder Humeral Fracture Stem with Macrobond - Prosthesis, internal, joint, shoulder, humeral component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218351
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218351

Zimmer Biomet Pty Ltd - Comprehensive Total Shoulder Humeral Fracture Stem with Macrobond -

Prosthesis, internal, joint, shoulder, humeral 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

10/12/2013

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 Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Comprehensive Total Shoulder Humeral Fracture Stem with Macrobond - Prosthesis, internal, joint,

shoulder, humeral component

Product Type

Single Device Product

Effective date

10/12/2013

GMDN

32835 Prosthesis, internal, joint, shoulder, humeral component

Functional description

Humeral component shoulder joint replacement prosthesis. Stem made from cobalt chome with a titanium

alloy Macrobond coating of the proximal surface for tuberosity reconstruction. Lateral and medial fins with

contoured suture holes for tuberosity fixation. Graduated hash marks for precise positioning and proper

reproduction of humeral height. For use with the Bio-Modular Humeral Heads and glenoid components

and Versa-Dial Humeral Heads.

Intended purpose

Humeral components with a MacroBond surface coating used for fractures of the proximal humerus as a

component for use in a total, reverse or partial shoulder replacements. Indicated for either cemented or

uncemented press-fit applications.

Variant information

Diameter (mm) 4-14

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 10:47:10 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

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