GENESIS

Main information

  • Trade name:
  • GENESIS II Biconvex Patella - Polyethylene patella prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • GENESIS II Biconvex Patella - Polyethylene patella prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220595
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220595

Smith & Nephew Pty Ltd - GENESIS II Biconvex Patella - Polyethylene patella 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

28/02/2014

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. GENESIS II Biconvex Patella - Polyethylene patella prosthesis

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

34199 Polyethylene patella prosthesis

Functional description

A polyethylene patellar implant designed to be cemented onto a reamed patella. The patella is measured

and an implant selected. A patellar reamer guide is used with a BLUE patellar depth gauge. Using the

BLUE patellar depth gauge and reamer guide, ream until the depth stop engages the reamer guide.

Following trialing, bone cement is applied to the reamed patella and the patellar implant is clamped onto it

using a patellar cement clamp. Excess cement should be removed following initial fixation.

Intended purpose

A sterile patellar component of a total knee system. The GENESIS II Biconvex Patellar Components are

indicated for the following conditions: rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or

degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

Variant information

Diameter (mm) 23-32

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 03:40:01 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