Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Adler Ortho Australia Pty Ltd - GENUS FB cementless tibial tray Ti-Por+HA coated - Coated knee tibia
ARTG entry for
Medical Device Included Class III
Adler Ortho Australia Pty Ltd
PO Box 1770,Capalaba, QLD, 4157
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.
Adler Ortho Srl
9 Via dell'innovazione
Cormano, MI, 20032
1. GENUS FB cementless tibial tray Ti-Por+HA coated - Coated knee tibia prosthesis
Single Device Product
34198 Coated knee tibia prosthesis
Ti6Al4V with porous titanium & HA coating. A fixed-bearing tibial component showing a non-anatomical
shape and a keel to be anchored to the bone. Keel features 2 delta-shaped wings. Central part is
truncated cone-shaped to anchor tibial stems. Locking system for tibial insert - step to be coupled to
flexible clips located in the anterior part of tibial insert; posterior part, stair to be coupled with a groove
located at the base of tibial insert avoids detachment of components.
A tibial component of a tricompartmental fixed-bearing prosthesis to be used in PCL (Posterior Cruciate
Ligament) retaining/sacrificing TKR (Total Knee Replacement) for primary and revision surgery. Main
- Primary and secondary arthrosis
- Rheumatoid arthritis
- Bone necrosis
- Revisions, where other devices or treatments have failed
No Specific Conditions included on Record
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Produced at 03.11.2017 at 11:22:30 AEDT
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