Summary for ARTG Entry:
Zimmer Pty Ltd - Vanguard SSK DCM non-constrained small post tibial bearing - Posterior-stabilized total
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
56 East Bell Drive
Warsaw, IN, 46581
United States Of America
1. Vanguard SSK DCM non-constrained small post tibial bearing - Prosthesis, internal, joint, knee, tot -
Posterior-stabilized total knee prosthesis
Single Device Product
33665 Posterior-stabilized total knee prosthesis
The Vanguard SSK DCM non-constrained small post tibial bearing is constructed of direct compression
moulded Arcom UHMWPE and articulates with the femoral and tibial tray components of the Vanguard
Super Stabilized Knee system. The device has a swept back tibial post and deep anterior cutout.
The Vanguard SSK Direct Compression Moulded Arcom UHMWPE non-constrained small post tibial
bearing is intended for use in treatment of low demand, less active or sedentary patients, as one
component of the Vanguard SSK total knee system. Indications for use for this knee system are:
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where
one or more compartments are involved; correction of varus, valgus, or posttraumatic deformity; correction
or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The
system is intended for application with or without cement in both primary and revision applications.
Size (mm) 59-75
Size (mm) 10-24
No Specific Conditions included on Record
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