Repicci

Main information

  • Trade name:
  • Repicci II Unicondylar Knee Onlay Poly tibial component - Uncoated unicondylar knee tibia prosthesis, polyethylene
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Repicci II Unicondylar Knee Onlay Poly tibial component - Uncoated unicondylar knee tibia prosthesis, polyethylene
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222552
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222552

Zimmer Pty Ltd - Repicci II Unicondylar Knee Onlay Poly tibial component - Uncoated unicondylar knee

tibia prosthesis, polyethylene

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

15/04/2014

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 Onlay Poly tibial component - Uncoated unicondylar knee tibia prosthesis,

polyethylene

Product Type

Single Device Product

Effective date

15/04/2014

GMDN

48069 Uncoated unicondylar knee tibia prosthesis, polyethylene

Functional description

Arcom UHMWPE onlay tibial component designed to be seated onto the prepared tibial surface; the

implant bone interface uses 4 pegs for rotational stability and added fixation. Reconstruction with this

implant rebalances the knee utilizing the remaining undisturbed compartmental structures and appropriate

soft tissue tensions as reference points.

Intended purpose

Arcom UHMWPE onlay tibial 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 cemented use only

Variant information

Size (mm) 6.5-9.5

Size Extra small-extra large

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 09.11.2017 at 09:05:55 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