Secur-Fit

Main information

  • Trade name:
  • Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219542
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219542

Stryker Australia Pty Ltd - Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

24/01/2014

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

33581 Coated hip femur prosthesis, modular

Functional description

A sterile implantable Femoral Hip Stem designed to replace the proximal femoral neck as part of a Hip

Arthroplasty. The proximal region of the stem is coated with PureFix HA over a commercially pure titanium

plasma spray substrate. Intraoperatively assembled with a Stryker V40 femoral head and a compatable

acetabular component. Intended for cementless use only.

Intended purpose

A component of a total hip joint prosthesis used to replace the femoral the femoral neck. Indications:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid

arthritis; correction of functional deformity; revision procedures where other treatments or devices have

failed; and, nonunions, femoral neck and trochanteric fractures of the proximal femur with head

involvement that are unmanageable using other techniques.

When used with compatible Howmedica Osteonics Constrained Liners, this device is intended for use in

primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss,

soft tissue laxity, neuromuscular disease, or intra-operative instability.

Variant information

Angle (In degrees) Neck Angle 132

Length (mm) Stem 110 -160

Length (mm) Neck Length 26mm - 40 mm

Offset Femoral Offset 31.5mm - 53.7mm

Diameter (mm) Distal Tip 5.1mm - 10.7mm

Angle (In degrees) Neck Angle 127

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 07:13:42 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

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We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy.pic.twitter.com/t

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THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

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FDA - U.S. Food and Drug Administration