S-ROM

Main information

  • Trade name:
  • S-ROM Noiles Dome Patella - Polyethylene patella prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • S-ROM Noiles Dome Patella - Polyethylene patella prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219087
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219087

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - S-ROM Noiles Dome Patella - Polyethylene

patella prosthesis

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

10/01/2014

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

Depuy Orthopaedics Inc

700 Orthopaedic Drive

Warsaw, IN, 46582

United States Of America

Products

1. S-ROM Noiles Dome Patella - Polyethylene patella prosthesis

Product Type

Single Device Product

Effective date

10/01/2014

GMDN

34199 Polyethylene patella prosthesis

Functional description

The S-ROM Noiles Dome Patella is made from polyethylene and is cemented onto the natural patella. The

S-ROM Noiles Dome Patella also contains an x-ray detectable wire of CoCr.

Intended purpose

The S-ROM Noiles Dome Patella is the petalla component of the S-ROM NOILES Rotating Hinge Knee

system which is indicated for use with bone cement in primary or revision cases in patients:

- who have reached skeletal maturity and

- for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are

absent or incompetent and

- who exhibit insufficiency of lateral/collateral ligaments and other soft supporting tissue due to the

following conditions: Rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to

variety of diseases and anomalies, failure of a previous knee reconstruction procedure or trauma.

Variant information

Diameter (mm) 30 - 38

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 01.12.2017 at 09:52:43 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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