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The SImmetry® Sacroiliac Joint Fusion is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm-14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm-14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).

The provided document describes a 510(k) premarket notification for the "SImmetry® Sacroiliac Joint Fusion System." This is a medical device, specifically a smooth or threaded metallic bone fixation fastener, and the submission is a "Special 510(k)." Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modifications do not affect the indications for use or the fundamental scientific technology of the device.

Based on the nature of this submission (a Special 510(k)) and the information provided, no acceptance criteria or studies proving the device meets those criteria are included in the document. The document explicitly states:

• "No performance data is required to support this Special 510(k)."
• "This Special 510(k) does not involve any changes to the technological characteristics of the device. The principle of operation of the subject device is identical to that of the predicate device cleared under K141549, SImmetry Sacroiliac Joint Fusion System."

Therefore, I cannot provide the requested information. The FDA's clearance for this device (K151818) is based on its substantial equivalence to a previously cleared predicate device (K141549), and not on a new study demonstrating its performance against specific acceptance criteria.

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