Repicci

Main information

  • Trade name:
  • Repicci II Unicondylar Knee Modular Tibial Bearing - Unicondylar knee insert
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Repicci II Unicondylar Knee Modular Tibial Bearing - Unicondylar knee insert
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221983
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221983

Zimmer Pty Ltd - Repicci II Unicondylar Knee Modular Tibial Bearing - Unicondylar knee insert

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

3/04/2014

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

Biomet Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Repicci II Unicondylar Knee Modular Tibial Bearing - Unicondylar knee insert

Product Type

Single Device Product

Effective date

3/04/2014

GMDN

48070 Unicondylar knee insert

Functional description

Arcom UHMWPE modular tibial bearing for use with Repicci II unicondylar modualr tibial tray.

Intended purpose

Arcom tibial bearing component of the Repicci Unicondylar Knee Joint Replacement Prosthesis.

Indications for use: Partial replacement of the articulating surfaces of the knee when only one side of the

joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease,

previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is

intended for use with the Repicci II modular tibial tray.

Variant information

Size Small-Extra large

Size (mm) 8-12

Shape Left medial/right lateral

Shape Right medial/left lateral

Specific Conditions

No Specific Conditions included on Record

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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 09.11.2017 at 11:02:26 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