Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Adler Ortho Australia Pty Ltd - GENUS PS MB tibial insert - Prosthesis, knee, internal, insert component
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 PS MB tibial insert - Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
Composed of UHMW-PE. Posterior cruciate ligament sacrificing mobile bearing insert, with a central pivot
to be coupled to the hole of the tibial component, so that rotation can occur. Post on the central part of the
articular surface. Mechanical interaction between the post and the cam of the GENUS PS femoral
component allows the roll-back mechanism to occur, avoiding the anterior luxation of the insert. Post and
cam show the same radius of curvature, so that shear stress can be minimized.
A tibial insert component of a tricompartmental rotating platform prosthesis to be used in PCL (Posterior
Cruciate Ligament) 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
Height (mm) 10-24
No Specific Conditions included on Record
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Produced at 03.11.2017 at 11:23:35 AEDT
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