Epoca

Main information

  • Trade name:
  • Epoca Metalback Glenoid - Prosthesis, internal, joint, shoulder, glenoid component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Epoca Metalback Glenoid - Prosthesis, internal, joint, shoulder, glenoid component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217184
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217184

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Epoca Metalback Glenoid - Prosthesis, internal,

joint, shoulder, glenoid component

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

12/11/2013

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

Synthes GmbH

3 Eimattstrasse

Oberdorf, , 4436

Switzerland

Products

1. Epoca Metalback Glenoid - Prosthesis, internal, joint, shoulder, glenoid component

Product Type

Single Device Product

Effective date

12/11/2013

GMDN

36259 Prosthesis, internal, joint, shoulder, glenoid component

Functional description

The metal back glenoid component is used in conjunction with a UHMPE glenoid implant on the glenoid

side and is then articulating with either a resurfacing head or a humeral head / humeral stem assembly.

The metal back glenoid may be fixed with 3.5 mm cortex screws at the bottom of the pegs for additional

stability. It is for cementless application.

Intended purpose

The metal back glenoid is a component of the Epoca shoulder prosthesis system and is intended for use

as a hemi- or total shoulder replacement. It ensures congruent glenohumeral implant surfaces to achieve

normal range of motion; Reduced size and beveled rim for normal mobility and reduced risk of

impingement.

Variant information

Diameter (mm) 42 to 54mm

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 02.12.2017 at 04:59:23 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