Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - PFC Sigma Curved XLK Tibial Insert -
Prosthesis, knee, internal, insert component
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 Orthopaedics Inc
700 Orthopaedic Drive
Warsaw, IN, 46582
United States Of America
1. PFC Sigma Curved XLK Tibial Insert - Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
The PFC Sigma Curved XLK Tibial Insert articulates with the femoral component and snap locks into the
tibial tray of a knee joint prosthesis. It is a one-piece contoured polymer insert.
The PFC Sigma Curved XLK Tibial Insert is the articulating component of a total knee arthroplasty and is
intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint
articulation in patients where there is evidence of sufficient sound bone to seat and support the
components. Candidates for total knee replacement include patients with a severely painful and/or
severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed
Size 1.5 to 6
Thickness 8 to 20mm
No Specific Conditions included on Record
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