Spectron

Main information

  • Trade name:
  • Spectron Revision Long Straight Femoral Component - Uncoated femoral stem prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Spectron Revision Long Straight Femoral Component - Uncoated femoral stem prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220103
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220103

Smith & Nephew Pty Ltd - Spectron Revision Long Straight 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

13/02/2014

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 Revision Long Straight Femoral Component - Uncoated femoral stem prosthesis, modular

Product Type

Single Device Product

Effective date

13/02/2014

GMDN

34203 Uncoated femoral stem prosthesis, modular

Functional description

A cemented Cobalt Chrome femoral stem with a 12/14 taper, circulotrapezoidal neck, and longitudinal

stem taper. The femoral canal is rasped with sequential broaches. After trialing and femoral canal

preparation, a Buck cement restrictor is inserted into the canal and cement is injected from a pressurized

gun. A stem driver is used to drive the stem into the femoral canal. Excess cement should be removed

prior to femoral head impaction on the neck taper.

Intended purpose

A sterile femoral component of a total hip system. The stem was designed for revision of femoral distal

defects such as holes, windows, or fractures around the end of the previously implanted stem.

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

Length (mm) 165-225

Size Small Medium and Large

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 05:17:37 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