Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIATHLON PRIMARY TIBIAL BASE PLATE CEMENTED - Uncoated knee tibia
ARTG entry for
Medical Device Included Class III
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
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.
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah, New Jersey, 07430
United States Of America
1. TRIATHLON PRIMARY TIBIAL BASE PLATE CEMENTED - Uncoated knee tibia prosthesis, metallic
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
A sterile implantable Tibial Tray/ Baseplate, designed to connect with a Tibial Insert that articulates with an
artificial Femoral Component of the Triathlon Total Knee Arthroplasty (TKA) System. Keel Design, with the
option for an extension stem to be attached, when required. Intended for use with cement. Made of Cobalt
A component of reconstructive knee system that connects with a tibial insert that articulates with a femoral
knee component. General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease
(including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to
adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur management techniques.
Width (mm) A/P 40mm - 59mm
Size 1 to 8
Width (mm) M/L 61mm - 85mm
No Specific Conditions included on Record
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