ECHELON

Main information

  • Trade name:
  • ECHELON Cemented Bowed Standard Collar Femoral Component - Uncoated femoral stem prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ECHELON Cemented Bowed Standard Collar Femoral Component - Uncoated femoral stem prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220232
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220232

Smith & Nephew Pty Ltd - ECHELON Cemented Bowed Standard Collar Femoral Component - Uncoated

femoral stem prosthesis, modular

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

18/02/2014

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 Inc Orthopaedic Division

1450 E Brooks Road

Memphis, TN, 38116

United States Of America

Products

1. ECHELON Cemented Bowed Standard Collar Femoral Component - Uncoated femoral stem prosthesis,

modular

Product Type

Single Device Product

Effective date

18/02/2014

GMDN

34203 Uncoated femoral stem prosthesis, modular

Functional description

A cemented Cobalt Chrome bowed femoral stem with trapezoidal distal cross section. The femoral neck is

resected and the canal is reamed incrementally. The femur is broached to size and the broach is seated

flush with the osteotomy level. Following reaming of the calcar and trialling, the femoral canal is prepared

and a Buck cement restrictor is inserted into the canal. Cement is injected into the canal from a

pressurized cement gun, and a stem inserter and mallet are used to seat the implant.

Intended purpose

A sterile femoral component of a total hip system. The Echelon cemented femoral implants are designed

for revision use in cases where the bone stock is not optimal for cementless fixation. The bowed design

accommodates the natural bow of the femur.

Hip components are indicated for individuals undergoing primary and revision surgery where other

treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory

degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis,

traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid

arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of

nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement

that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone

resection; fracture/dislocation of the hip; and correction of deformity.

Variant information

Size 12 and 14

Shape Left and Right

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 10.11.2017 at 04:50:49 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