R3 Biolox

Main information

  • Trade name:
  • R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218185
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218185

Smith & Nephew Pty Ltd - R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner

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

6/12/2013

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. R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner

Product Type

Single Device Product

Effective date

6/12/2013

GMDN

48055 Ceramic acetabular liner

Functional description

The sterile, alumina zirconia liner is placed into an acetabular shell and seated with an impactor and

mallet. It provides an articulating surface for the acetabular prosthesis to interface with a ceramic Biolox

Delta femoral head prosthesis during total hip arthroplasty. The liner features an outer titanium ring

offering greater protection against chipped edges and tensile forces.

Intended purpose

Acetabular liner component of the cementless R3 Acetabular System. 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

Diameter (mm) Outer 48 to 66/68mm

Diameter (mm) Inner 32 or 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 11:30:42 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