Summary for ARTG Entry:
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
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 PEEK Anchors with Orthocord - Anchor, bone-implanted, soft-tissue,
Single Device Product
45062 Soft-tissue anchor, non-bioabsorbable
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.
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
Diameter (mm) 4.75 - 6.5
No Specific Conditions included on Record
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