ANTHOLOGY

Main information

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

Documents

Localization

  • Available in:
  • ANTHOLOGY Porous Plus HA Femoral Component - Coated femoral stem prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218143
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218143

Smith & Nephew Pty Ltd - ANTHOLOGY Porous Plus HA Femoral Component - Coated 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

5/12/2013

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. ANTHOLOGY Porous Plus HA Femoral Component - Coated femoral stem prosthesis, modular

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

34191 Coated femoral stem prosthesis, modular

Functional description

A porous, hydroxyapatite-coated one-piece titanium alloy femoral component is inserted into a prepared

femoral canal following femoral head osteotomy. The femoral canal is rasped with sequential broaches

until it reaches the templated stem size. Following trial reduction with a broach/trial, standard or high offset

neck trial, and femoral head trial, a stem inserter is used to rotate and place the stem. It is seated into the

femur with a mallet and a femoral head is impacted on the neck taper.

Intended purpose

A sterile femoral component of a total hip system. It is designed to mate with either a femoral head or a

femoral sleeve and modular head. It is intended to be used in primary total hip replacement and without

bone cement.

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 Standard or High

Size 1 to 12

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 11:41:03 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