Summary for ARTG Entry:
Smith & Nephew Pty Ltd - GENESIS II Biconvex Patella - Polyethylene patella prosthesis
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. GENESIS II Biconvex Patella - Polyethylene patella prosthesis
Single Device Product
34199 Polyethylene patella prosthesis
A polyethylene patellar implant designed to be cemented onto a reamed patella. The patella is measured
and an implant selected. A patellar reamer guide is used with a BLUE patellar depth gauge. Using the
BLUE patellar depth gauge and reamer guide, ream until the depth stop engages the reamer guide.
Following trialing, bone cement is applied to the reamed patella and the patellar implant is clamped onto it
using a patellar cement clamp. Excess cement should be removed following initial fixation.
A sterile patellar component of a total knee system. The GENESIS II Biconvex Patellar Components are
indicated for the following conditions: rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or
degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
Diameter (mm) 23-32
No Specific Conditions included on Record
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