Pinnacle

Main information

  • Trade name:
  • Pinnacle Constrained Acetabular Liner - Constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Pinnacle Constrained Acetabular Liner - Constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222179
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222179

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Pinnacle Constrained Acetabular Liner -

Constrained polyethylene acetabular liner

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

8/04/2014

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

Depuy Orthopaedics Inc

700 Orthopaedic Drive

Warsaw, IN, 46582

United States Of America

Products

1. Pinnacle Constrained Acetabular Liner - Constrained polyethylene acetabular liner

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

44362 Constrained polyethylene acetabular liner

Functional description

The Pinnacle Constrained Acetabular Liner is manufactured from cross-linked UHMWPE, which locks into

an outer shell component. The liner component articulates with a metal femoral head of an appropriate

diameter. The Pinnacle Constrained Acetabular Liner mechanically constrains the femoral head within the

inner diameter of the liner with a titanium constraining ring which fits over the opening diameter of the liner.

The UHMWPE liner is held in the metal shell by means of a titanium locking ring.

Intended purpose

The Pinnacle Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in

primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss,

joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Variant information

Diameter (mm) Outer Diameter: 48-76

Diameter (mm) Inner Diameter: 28-44

Offset +4 10deg

Offset +4 Neutral

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 02.12.2017 at 04:14:44 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

29-6-2018

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Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

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