Tenon Medical earned FDA 510(k) clearance to use its Catamaran sacroiliac joint system for augmenting thoracolumbar fusion, according to a March 24 news release.
With the new indication Catamaran can be used as a standalone treatment or to augment spinal fusion.
In October, the company shared interim data on Catamaran that supported the device’s safety and efficacy. The system, designed to transfix the SI joint along its longitudinal axis can be implanted in less than an hour in an outpatient setting.
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