REFLECTION

Main information

  • Trade name:
  • REFLECTION Multi-Hole Porous Acetabular Shell - Acetabular shell
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • REFLECTION Multi-Hole Porous Acetabular Shell - Acetabular shell
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220233
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220233

Smith & Nephew Pty Ltd - REFLECTION Multi-Hole Porous Acetabular Shell - Acetabular shell

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

18/02/2014

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. REFLECTION Multi-Hole Porous Acetabular Shell - Acetabular shell

Product Type

Single Device Product

Effective date

18/02/2014

GMDN

43167 Acetabular shell

Functional description

The hemispherical acetabular shell features a porous coating to enhance stability. After removal of prior

implants and any cement, the acetabular host bone is reamed sequentially. The shell is inserted into the

acetabulum and tapped with a mallet until firmly seated. The apex hole is sealed with a watertight cover.

Spherical head or universal screws or locking head pegs are inserted into holed shells and unused holes

are covered with the appropriate screw hole covers prior to liner insertion.

Intended purpose

A sterile acetabular component of a total hip system. REFLECTION Multi-Hole Porous Acetabular Shell is

a titanium alloy porous coated acetabular shell being the outer portion of a two-piece acetabulum

prosthesis intended for revision surgery and 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 (mm) 50 to 68

Number of holes 8 or 12

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 04:50:33 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

There are no safety alerts related to this product.

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