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Mighty Oak Medical receives second FDA clearance for 3-D printed patient-specific pedicle screw guides
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Mighty Oak Medical announced it has received a second FDA clearance for its patient-specific 3-D printed Firefly pedicle screw navigation guides.
According to a release, the FDA clearance extends the indications for use to T1-S2/ilium. The technology has reportedly received two Spine Technology Awards for 3-D printed patient-specific solutions to challenges in spinal surgery. Reportedly, Firefly features pre-surgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, preselected trajectories that are surgeon-approved, an intraoperative plan and 3-D printed patient-specific guides to mechanically restrict the drill and tap to follow the pre-selected trajectories. Firefly was created to increase OR efficiency and reportedly is the only patient-specific pedicle screw guide indicated for use in pediatric patients.
“Firefly technology is at the epicenter of three strong trends: 3-D printing, personalized medicine and pre-surgical planning,” Brent Ness, chief operating officer for Mighty Oak, said in the release. “It is uniquely situated to bring navigation to standard of care around the world.”
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