Summary for ARTG Entry:
MicroPort Orthopedics Pty Ltd- ADVANCE® Revision Nonporous CoCr Femoral Knee Components -
Uncoated knee femur prosthesis
ARTG entry for
Medical Device Included Class III
MicroPort Orthopedics Pty Ltd
PO Box 6052,Frenchs Forest, NSW, 1640
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.
MicroPort Orthopedics Inc
5677 Airline Road
Arlington, TN, 38002
United States Of America
1. Uncoated knee femur prosthesis
Single Device Product
32831 Uncoated knee femur prosthesis
A nonporous CoCr device with a spine and cam mechanism used to replace the distal femur of a knee
joint in skeletally mature patients. It accepts traditional posterior-stabilized or constrained UHMWPE tibial
inserts and, if required, UHMWPE patellar components of the knee joint. This device is indicated for use in
both primary and revision knee replacement surgeries; however, it is mainly used in revision scenarios
when additional constraint and fixation (via stem extensions) are required.
A total knee system component used to replace the distal femur. Indicated for use in knee arthroplasty in
skeletally mature patients with the following conditions:
1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular
2. Inflammatory degenerative joint disease including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are
unmanageable using other techniques.
Shape left & right
No Specific Conditions included on Record
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