Ringloc

Main information

  • Trade name:
  • Ringloc Arcom acetabular liner 10 degree - Non-constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ringloc Arcom acetabular liner 10 degree - Non-constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217831
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217831

Zimmer Pty Ltd - Ringloc Arcom acetabular liner 10 degree - Non-constrained polyethylene acetabular liner

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

28/11/2013

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

Biomet Orthopedics

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Ringloc Arcom acetabular liner 10 degree - Non-constrained polyethylene acetabular liner

Product Type

Single Device Product

Effective date

28/11/2013

GMDN

43168 Non-constrained polyethylene acetabular liner

Functional description

The Ringloc Arcom acetabular liner is used with a Ringloc acetabular shell and is made of UHMWPE. A

groove around the outer periphery of the liner is intended to engage with a floating metal ring located in

the periphery of the metal shell component, providing a liner locking mechanism.

Intended purpose

The Ringloc Arcom UHMWPE 10 degree acetabular liner is intended for both primary and revision

applications for the following indications:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with

head involvement, unmanageable using other techniques.

5. Revision procedures where other treatment or devices have failed.

Variant information

Diameter (mm) 28-32

Size 21-28

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 12:51:39 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