Summary for ARTG Entry:
Smith & Nephew Pty Ltdy Ltd - PROFIX Non-Porous Tibial Base - Uncoated knee tibia prosthesis, metallic
ARTG entry for
Medical Device Included Class III
Smith & Nephew Pty Ltd
PO Box 393, North Ryde, NSW, 1670
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.
Smith & Nephew Inc Orthopaedic Division
1450 E Brooks Road
Memphis, TN, 38116
United States Of America
1. PROFIX Non-Porous Tibial Base - Uncoated knee tibia prosthesis, metallic
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
A non-porous tibial component with horizontal cement grooves and a grit-blasted surface. Following
resection of the tibia, trialing and then punching with the Nonporous Tibial Fin Punch, the tibial implant
undersurface is coated with bone cement and positioned using the Tibial Rotation Alignment Guide and
impacted onto the proximal tibia using the tibial impactor. After insert thickness is determined, the insert is
placed onto the tibial implant and the peripheral locking mechanism is engaged.
A sterile tibial base component of a total knee system. PROFIX Non-Porous Tibial Base components are
indicated for the following conditions: rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or
degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
Width (mm) 42-61
Length (mm) 61-91
Shape Left and Right
No Specific Conditions included on Record
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