Main information

  • Trade name:
  • Echelon Porous Plus HA Standard Collar Femoral Component - Coated femoral stem prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Echelon Porous Plus HA Standard Collar Femoral Component - Coated femoral stem prosthesis, modular
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222602
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Smith & Nephew Pty Ltd - Echelon Porous Plus HA Standard Collar Femoral Component - Coated femoral

stem prosthesis, modular

ARTG entry for

Medical Device Included Class III


Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Smith & Nephew Inc Orthopaedic Division

1450 E Brooks Road

Memphis, TN, 38116

United States Of America


1. Echelon Porous Plus HA Standard Collar Femoral Component - Coated femoral stem prosthesis, modular

Product Type

Single Device Product

Effective date



34191 Coated femoral stem prosthesis, modular

Functional description

A Cobalt Chrome straight femoral stem with a RoughCoat porous plus hydroxyapatite coating to the

implant tip. The stem has a standard collar, a circulotrapezoidal neck providing an increased range of

motion, a threaded driving platform with an elliptical slot for rotational and axial implant control during

insertion. Following sequential reaming and broaching of the femur, the calcar is reamed and the stem

trialed. The stem is impacted into place using a threaded stem inserter and a mallet.

Intended purpose

The ECHELON Porous Plus HA Standard Collar stem is a femoral component of a total revision hip


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

Offset 40-50mm

Length (mm) Neck length 37-41mm

Size 11-20

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

Public Summary

Page 1 of

Produced at 09.11.2017 at 08:55:21 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.

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