Spectron

Main information

  • Trade name:
  • Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated femoral stem prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated femoral stem prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220401
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220401

Smith & Nephew Pty Ltd - Spectron EF Primary 12/14 Taper CoCr 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

24/02/2014

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. Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated femoral stem prosthesis, modular

Product Type

Single Device Product

Effective date

24/02/2014

GMDN

34203 Uncoated femoral stem prosthesis, modular

Functional description

A cobalt chrome alloy cemented femoral hip stem which features: a roughened proximal surface which

increases the implant surface area leading to a stronger bond at the implant/cement interface;

a polished circulotrapezoidal neck for increased range of motion of the joint and decreased impingement

and dislocation; 12/14 taper compatibility with 12/14 taper femoral head; and, a rectangular cross section

through the distal portion of the stem for rotational stability.

Intended purpose

A sterile cobalt-chrome femoral component of a total hip system intended to be used with 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

Size 1H-5H High

Offset Standard and High

Size 1-5 Standard

Length (mm) 115-135

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 04:12:29 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