S-ROM

Main information

  • Trade name:
  • S-ROM ZTT Proximal Sleeve - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • S-ROM ZTT Proximal Sleeve - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219086
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219086

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - S-ROM ZTT Proximal Sleeve - Coated hip femur

prosthesis, modular

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 ZTT Proximal Sleeve - Coated hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

10/01/2014

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

The S-ROM ZTT Proximal Sleeves are made out of Titanium and are porous coated for cementless use

only. The S-ROM ZTT Proximal Sleeves are used with the S-ROM femoral stem to help achieve proximal

fill during hip arthroplasty.

Intended purpose

The S-ROM ZTT Proximal Sleeves are used with the S-ROM femoral stem to help achieve proximal fill.

The components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures

for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid

arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of

femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for

patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability

due to previous fusion.

Variant information

Size Oversize

Size Standard

Size XXL

Size Undersize

Size 12 - 24

Size LRG

Size SML

Size B or D or F

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 09:52:58 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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