Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - MILAGRO Advance Interference Screw -
Fixation screw, bone, 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. MILAGRO Advance Interference Screw - Fixation screw, bone, biodegradable
Single Device Product
45039 Fixation screw, bone, biodegradable
The MILAGRO ADVANCE Interference Screws are absorbable, tapered, cannulated and threaded
interference screws manufactured from Biocryl Rapide material. The screw is designed for use in
interference fixation of soft tissue grafts or bone-tendon-bone grafts to bone.
The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or
bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.
Additionally, the 7, 8 and 9 mm x 23 mm screws are indicated for: medial and lateral collateral ligament
repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Length (mm) 23-35
Diameter (mm) 7-12
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:43:48 AEDT
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