EP-FIT

Main information

  • Trade name:
  • EP-FIT PLUS REXPOL Insert Hooded - Acetabulum prosthesis - Non-constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • EP-FIT PLUS REXPOL Insert Hooded - Acetabulum prosthesis - Non-constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222566
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222566

Smith & Nephew Pty Ltd - EP-FIT PLUS REXPOL Insert Hooded - Non-constrained polyethylene

acetabular liner

ARTG entry for

Medical Device Included Class III

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

16/04/2014

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

Smith & Nephew Orthopaedics AG

Oberneuhofstrasse 10d

Baar, , 6340

Switzerland

Products

1. EP-FIT PLUS REXPOL Insert Hooded - Acetabulum prosthesis - Non-constrained polyethylene acetabular

liner

Product Type

Single Device Product

Effective date

16/04/2014

GMDN

43168 Non-constrained polyethylene acetabular liner

Functional description

A sterile non-cemented REXPOL (highly cross-linked polyethylene) acetabular insert having a raised

shoulder of 15 degrees intended as luxation protection. The insert should be positioned in the direction in

which there is the greatest risk of luxation and the shoulder position of the insert may be adjusted in 30

degree increments. The REXPOL Hooded insert is impacted into the acetabular shell using an

inserter/impactor.

Intended purpose

An acetabular component of the EP-FIT PLUS Press-Fit cup system. The EP-FIT PLUS REXPOL Insert

Hooded is intended to be used for the following indications:

· All forms of arthritis

· Progressive loss of function of the hip joint as a result of degenerative posttraumatic or

inflammatory/rheumatic destruction of the joint

· Femoral head necrosis

· Fractures in the region of the femoral neck or hip joint

· Status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint

replacement

Variant information

Size 46 - 68

Diameter (mm) Inner diameter 28 - 32

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 09.11.2017 at 09:02:54 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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