Mighty Oak Medical Receives FDA Clearance for Its FIREFLY Pedicle Screw Navigation Guide

FIREFLY Technology uses 3D printing to create a patented patient-specific solution for misplaced pedicle screws in spinal fusion surgery.

Mighty Oak Medical announced that it has received 510(k) approval from the FDA for its patented, 3D printed, patient-specific FIREFLY™ Pedicle Screw Navigation Guide. FIREFLY Technology enables optimal implant placement by incorporating surgeon-defined parameters for screw diameter, medial line angle, and entry point into the design of the patient-specific Guides.  Additionally, as a result of the concierge presurgical planning performed by Mighty Oak Medical and approved by the surgeon, implant sizing is determined preoperatively. By front-loading these activities to take place preoperatively instead of intraoperatively, FIREFLY enhances quality of care, and impressive efficiencies and cost-savings can be achieved in the operating room. FIREFLY Guides do not have a proprietary screw system, and can be used with multiple pedicle screw manufacturer’s systems. FIREFLY Technology uses 3D printing to make navigation more accessible to surgeons and patients, and addresses some of the problems faced by current navigation platforms.

“FIREFLY navigational guides represent a major step towards a future for spinal navigation that is both intuitive and uncomplicated, while maintaining an unmatched level of accuracy and minimal radiation exposure. I believe that spinal navigation will eventually become a standard of care in the operating room, demanded by surgeon and patient alike. FIREFLY will help to make that possible.” – Dr. George Frey

Mighty Oak Medical, located in Englewood, Colorado, is a medical device development company for cutting-edge spinal technologies. It was awarded the Spine Technology Award in 2012 for FIREFLY Technology, and was a recipient of the Advanced Industries Grant from the State of Colorado in 2015.

For additional information, please contact Mighty Oak Medical at 720-398-9703.

Categories: Healthcare, Surgery, Orthopedics

Tags: 3D printing, pedicle screws, personalized medicine, presurgical planning, spine