Regenerex

Main information

  • Trade name:
  • Regenerex RingLoc Plus Solid Shell with Apical Hole - Acetabular shell
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Regenerex RingLoc Plus Solid Shell with Apical Hole - Acetabular shell
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221474
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221474

Zimmer Pty Ltd - Regenerex RingLoc Plus Solid Shell with Apical Hole - Acetabular shell

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

19/03/2014

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. Regenerex RingLoc Plus Solid Shell with Apical Hole - Acetabular shell

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

43167 Acetabular shell

Functional description

The Regererex RingLoc Plus Solid Shell with Apical Hole with lock ring with plug accepts a polyethylene

liner component for articulation with the femoral head. The device is manufactured from Titanium Alloy.

Intended purpose

The Regenerex RingLoc Plus Solid Shell with Apical Hole is a part of the Regenerex Acetabular Hip

System that is intended for: Noninflammatory degenerative joint disease including osteoarthritis and

avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Treatment of non-union,

femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement,

unmanageable using other techniques; and Revision procedures where other treatment or devices have

failed.

Variant information

Diameter (mm) 48-72

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 12:56:21 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