Delta

Main information

  • Trade name:
  • Delta Cup Liner UHMWPE X-LIMA + Ti6Al4V - Non-constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Delta Cup Liner UHMWPE X-LIMA + Ti6Al4V - Non-constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218819
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218819

Lima Orthopaedics Australia Pty Ltd - Delta Cup Liner UHMWPE X-LIMA + Ti6Al4V - Non-constrained

polyethylene acetabular liner

ARTG entry for

Medical Device Included Class III

Sponsor

Lima Orthopaedics Australia Pty Ltd

Postal Address

Unit 1 40 Ricketts Road,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

24/12/2013

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

Limacorporate Spa

Via Nazionale 52

Villanova San Daniele del Friuli, Udine, 33038

Italy

Products

1. Delta Cup Liner UHMWPE X-LIMA + Ti6Al4V - Non-constrained polyethylene acetabular liner

Product Type

Single Device Product

Effective date

24/12/2013

GMDN

43168 Non-constrained polyethylene acetabular liner

Functional description

The inner portion of a two-piece acetabulum prosthesis that provides an articulating surface for the

acetabulum prosthesis, after insertion into an acetabular shell, to interface with a femoral head prosthesis

as part of a total hip arthroplasty.

Intended purpose

The inner portion of a two-piece acetabulum prosthesis that is made of polyethylene and supplied sterile

that provides an articulating surface for the acetabulum prosthesis, after insertion into an acetabular shell,

to interface with a femoral head prosthesis as part of a total hip arthroplasty (THA).

Variant information

Shape Neutral

Shape Protruded

Size Small to Large

Diameter (mm) 28 to 36

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 05:29:27 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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