Healix

Main information

  • Trade name:
  • Healix Advance Knotless PEEK Anchors with Orthocord - Anchor, bone-implanted, soft-tissue, non-biodegradable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Healix Advance Knotless PEEK Anchors with Orthocord - Anchor, bone-implanted, soft-tissue, non-biodegradable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217857
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217857

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Healix Advance Knotless PEEK Anchors with

Orthocord - Anchor, bone-implanted, soft-tissue, non-biodegradable

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

29/11/2013

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

Depuy Mitek (a Johnson & Johnson Company)

325 Paramount Drive

Raynham, MA, 02767

United States Of America

Products

1. Healix Advance Knotless PEEK Anchors with Orthocord - Anchor, bone-implanted, soft-tissue,

non-biodegradable

Product Type

Single Device Product

Effective date

29/11/2013

GMDN

45062 Soft-tissue anchor, non-bioabsorbable

Functional description

The HEALIX ADVANCE™ KNOTLESS Anchors are one piece implants, consisting of PEEK

(Polyetheretherketone). The HEALIX ADVANCE KNOTLESS PEEK Anchors are sterile implants designed

to secure soft tissue to bone when used in conjunction with high-strength #2 Orthocord suture. They are

preloaded onto a stainless steel shaft/handle.

Intended purpose

The Healix Advance Knotless PEEK Anchors are indicated for use in the following procedures for

reattachment of soft tissue to bone.

- Rotator Cuff

- Bicep tenodesis

Variant information

Diameter (mm) 4.75 - 6.5

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 04:51:02 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