English - Integra Cadence Total Ankle System Manual

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 a tibial tray, a talar dome and
an insert. Both the tibial tray and talar dome are secured to
patient anatomy; 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.
Material
The talar dome components are made out of Cobalt Chrome
alloy (CoCr) according to ASTM F1537 and ASTM F75, with a
porous titanium coating (Ti).
The tibial tray components are made out of Titanium alloy
(Ti) Ti-6Al-4V ELI Per ASTM F136, with a porous titanium
coating (Ti).
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)
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