Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Healix Advance Knotless BR Anchors with
Orthocord - Fixation anchor, soft-tissue, biodegradable
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class III
- 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.
Depuy Mitek (a Johnson & Johnson Company)
325 Paramount Drive
Raynham, MA, 02767
United States Of America
1. Healix Advance Knotless BR Anchors with Orthocord - Fixation anchor, soft-tissue, biodegradable
Single Device Product
45061 Fixation anchor, soft-tissue, biodegradable
The HEALIX ADVANCE™ KNOTLESS BR Anchors are one piece implants, consisting of BIOCRYL®
RAPIDE™ (BR), an absorbable composite material (PLGA/TCP). The HEALIX ADVANCE KNOTLESS BR
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.
The Healix Advance Knotless BR Anchors are indicated for use in the following procedures for
reattachment of soft tissue to bone.
- Rotator Cuff
- Bicep tenodesis
Diameter (mm) 4.75 - 6.5
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.
Page 1 of
Produced at 02.12.2017 at 04:51:18 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