Mighty Oak Medical Receives Second FDA Clearance
November 7, 2016
Mighty Oak Medical (http://www.mightyoakmedical.com) announced today that its patient-specific, 3D printed FIREFLY® Pedicle Screw Navigation Guides have received a second FDA clearance extending compatibility to essentially all currently cleared pedicle screw systems. The new clearance also extends the indications for use to T1-S2/ilium. By choice, Mighty Oak does not have its own proprietary screw system, and is actively collaborating with strategic channel partners.
At the recent NASS meeting, a number of complex navigation options were on display in the $1 million range.With navigation gaining traction as a way to improve screw placement accuracy, surgeon interest is high. But in light of health care economics today, it will be a struggle for navigation to become standard of care at a $1 million price point.
FIREFLY® Pedicle Screw Navigation Guides are a notable exception to the prevailing complexity and expense of current navigation equipment. The FIREFLY® Technology platform has already received two prestigious Spine Technology Awards for its 3D printed patient-specific solutions to challenges in spinal surgery, including the one it received last week.
FIREFLY® does not require an upfront capital expenditure and is single-use and scalable. It features concierge pre-surgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, surgeon-approved preselected trajectories, an intraoperative plan, and 3D printed patient-specific guides to mechanically constrain the drill and tap to follow the preselected trajectories…
