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The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850 and K131405.

This document, an FDA 510(k) summary for the iFuse Implant System®, details a premarket notification for a medical device. However, it explicitly states that "No performance testing was required to support the modified labeling that is the subject of this 510(k)." Therefore, the document does not contain information on acceptance criteria or a study proving the device meets said criteria as it pertains to this specific submission.

The 510(k) is for a modification to labeling of an already existing and previously cleared device (iFuse Implant System). The submission focuses on demonstrating substantial equivalence to its predicate device rather than presenting new performance data.

Consequently, I cannot provide the requested information from the provided text, as the study details and acceptance criteria are not present.

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