Tornier, Inc. designs, manufactures and markets a wide array of joint replacement and tissue repair devices. Tornier shoulder replacement products include the Ascend, Aequalis Ascend Flex, and Simpliciti lines.
Cleared by the U.S. Food & Drug Administration (FDA) in 2012, the Ascend Shoulder System consists of a titanium humeral stem (either Titanium Plasma Spray coated or un-coated version), a mating humeral head, and an optional polyethylene glenoid (socket). The Ascend System is indicated for use in patients who require shoulder replacement due to:
The Ascend Shoulder System is only indicated for use in patients with an intact or reconstructable rotator cuff.
Tornier’s Aequalis Ascend Flex System was initially cleared by the FDA in 2013, and may be used in primary, reverse, or conversion (from anatomic to reverse) procedures. It is indicated for patients who require shoulder replacement due to:
The Aequalis Ascend Flex Shoulder System consists of various components, depending on the configuration. Some of these include a titanium humeral stem (either Titanium Plasma Spray coated or un-coated version), as well as a cobalt-chromium humeral head with a compatible glenoid.
The Aequalis Ascend Flex System is intended to be used in individuals who have a functional deltoid muscle with a massive, non-repairable rotator cuff tear.
Cleared by the FDA in 2015, the Tornier Simpliciti Shoulder System is indicated for total shoulder replacement in patients who have a severely painful and/or disabled joint as a result of osteoarthritis or traumatic arthritis. The metaphyseal humeral stem, which is constructed of titanium alloy, is indicated for press-fit, uncemented use. The humeral heads are made of cobalt-chromium- alloy. The polyethylene glenoid components are indicated for cemented use only.
In a press release announcing its FDA clearance, Tornier characterized the Simplicity System as a “novel, first to market system in the United States” which would provide “surgeons with an efficient, repeatable surgical technique that is intended to preserve both the patient’s native bone and avoid further trauma to the surrounding soft tissue.”
Complications that may be associated with any type of shoulder replacement surgery include:
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