Biolox

Main information

  • Trade name:
  • Biolox Delta Ceramic Femoral Head 12/14 Taper - Ceramic femoral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Biolox Delta Ceramic Femoral Head 12/14 Taper - Ceramic femoral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218138
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218138

Smith & Nephew Pty Ltd - Biolox Delta Ceramic Femoral Head 12/14 Taper - Ceramic femoral head

prosthesis

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. Biolox Delta Ceramic Femoral Head 12/14 Taper - Ceramic femoral head prosthesis

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

38156 Ceramic femoral head prosthesis

Functional description

A sterile implantable artificial femoral head that is made of an alumina zirconia material composite

designed to mate with a hip stem through a corresponding 12/14 taper and to articulate with an acetabular

prosthesis as part of total hip arthroplasty. Following a trial reduction with a femoral head trial, the neck

taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and

firmly impacted with a mallet.

Intended purpose

A sterile implantable spherical component of a total hip system intended to replace the anatomical femoral

head. It attaches to the trunnion of a femoral stem prosthesis and articulates with an acetabulum

prosthesis. 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) Neck Short +0 Medium +4 Long +8

Extra Long +12

Size (mm) 32 and 36

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 11:42:23 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