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FDA issues clearance for Picasso II

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AccelSPINE received FDA clearance for its Picasso II, a double-lead thread and self-tapping screw.

According to a company press release, the Picasso II immobilizes and stabilizes spinal segments in skeletally mature patients as a supplement to fusion during the treatment of acute and chronic instabilities or deformities of the upper or lower spine, or the sacral region. It is a continuation of Picasso I, which was given FDA clearance in 2012, according to a press release.

“The difference between Picasso I and Picasso II is the double-lead thread and self-tapping, anodized screw that streamlines the implant process. This is an evolutionary system that was designed based on input from our surgeons. We continually ask our surgeons for feedback on our products so that we can bring to market the best and most innovative products possible,” Estella Baytan, vice president of marketing and clinical operations for AccelSPINE, stated in the release.