En - English - Integra Cadence Total Ankle System Gebrauchsanweisung

Cadence Total Ankle System
®
Instructions for Use
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
Description
The Cadence® Total Ankle System is designed to treat ankle arthritis through
replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring
alignment, and allowing for movement at the replaced joint.
The prosthesis is composed of three components: a tibial tray, an insert and one of two
talar dome options; a chamfer cut talar dome or a flat cut talar dome. Both the tibial
tray and talar dome are secured to patient anatomy via bone cement (US only); the
insert is rigidly fixed to the tibial tray intra-operatively. When all three components
are implanted, the insert acts as a bearing along the talar dome, enabling flexion and
extension movement at the replaced joint.
Each of the three components is available in a variety of sizes and design configurations
intended for both primary surgery and revision surgery applications. For component
and size options, refer to the following chart.
1x
1
1
1
1
2x 3x 4x
2 3 4 5
2 3 4 5
2 3 4 5
2 3 4
Material
The talar dome components are made out of Cobalt Chromium alloy (CoCr) according
to ASTM F1537 or ASTM F75, with a porous commercially pure titanium coating (cpTi)
per ASTM F1580.
The tibial tray components are made out of Titanium alloy Ti-6Al-4V ELI per ASTM F136,
with a porous commercially pure titanium coating (cpTi) per ASTM F1580.
The insert is made out of highly cross-linked polyethylene UHMWPE, according to ISO
5834-2 and ASTM F648.
Magnetic Resonance (MR) Statement
The Cadence Total Ankle System has not been evaluated for safety and compatibility in
the MR environment. It has not been tested for heating, migration, or image artifact in
the MR environment. The safety of Cadence Total Ankle System in the MR environment
is unknown. Scanning a patient who has this device may result in patient injury.
Indications for Use
The Cadence Total Ankle System is designed to treat ankle arthritis through
replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring
alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
• Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
• Primary arthritis (e.g. degenerative disease)
• Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the
talus is preserved)
The Cadence Total Ankle System is also indicated for revision surgeries following failed
total ankle replacement and non-union/mal-union of ankle arthrodesis, provided
sufficient bone stock is present.
Note: In the United States, this device is intended for cemented use only.
Note: Outside the United States, this device is intended for cemented or cementless
use.
Contraindications
The Cadence Total Ankle System is contraindicated for:
• Active infection
• Skeletally immature
• Pregnancy
• Suspected or documented metal allergy or intolerance
• Severe avascular necrosis of the talus/tibia
• Severe malalignment or instability that is not surgically correctable
• Neurological or musculoskeletal disease that may adversely affect gait or weight
bearing
• Participation in activities that may exert excessive loading on joint area and
prosthesis
• Inadequate neuromuscular status (e.g., prior paralysis, neuropathy)
• Poor bone stock, poor skin coverage, or excessive bone loss around the joint which
would make the procedure unjustifiable
2
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