It depends whether or not SPORT will require Pre-market notification or Pre-market approval. PMN 510(k) clearance typically requires minimal human clinical data. If a company can show its device is as safe and effective (substantially equivalent) to a legally marketed device (ie Da Vinci) that is not subject to premarket approval, the FDA will not require a significant amount of clinical trial data. The animal data and pending European field data would most likely be sufficient to show safety/efficacy
A PMA on the other hand is a more stringent device marketing application required by the FDA. PMA approval is based on a determination by the FDA that the application is backed by a sufficient amount of valid safety and efficacy data. If SPORT is designated a Class III device, it will require a PMA.
From everything Ive read/heard so far, Titan expects to get 510(k) clearance. If so, they should be able to stay on schedule.
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