LCS Complete

Main information

  • Trade name:
  • LCS Complete RP Tibial Insert - Prosthesis, knee, internal, insert component
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • LCS Complete RP Tibial Insert - Prosthesis, knee, internal, insert component
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217376
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217376

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - LCS Complete RP Tibial Insert - Prosthesis,

knee, internal, insert 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

15/11/2013

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

Depuy Orthopaedics Inc

700 Orthopaedic Drive

Warsaw, IN, 46582

United States Of America

Products

1. LCS Complete RP Tibial Insert - Prosthesis, knee, internal, insert component

Product Type

Single Device Product

Effective date

15/11/2013

GMDN

46585 Prosthesis, knee, internal, insert component

Functional description

The LCS Complete RP Tibial Insert articulates with the femoral component and rotates on the surface of

the tibial tray of a knee joint prosthesis. It is a one-piece contoured UHMWPE insert.

Intended purpose

The LCS Complete RP Tibial Insert is the articulating component of a total knee arthroplasty and is

intended for noncemented use in skeletally mature individuals undergoing primary surgery for

reconstructing knees damaged as a result of noninflammatory degenerative joint disease (NIDJD) or either

of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies.

Variant information

Size LG+

Size LG

Size MED

Size STD+

Size STD

Size SM+

Size SM

Thickness 10 to 25mm

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 04:57:46 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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