Mighty Oak Medical Receives 2nd FDA Clearance for 3D-Printed FIREFLY Pedicle Screw Guides
Mighty Oak Medical received a second FDA 510(k) clearance for patient-specific, 3D-printed FIREFLY® Pedicle Screw Navigation Guides, extending compatibility to essentially all currently cleared pedicle screw systems and extending indications to include the T1-S2/ilium region.
The initial 510(k) clearance for FIREFLY was granted in December 2015.
Mighty Oak does not have its own proprietary screw system, and is actively collaborating with strategic channel partners such as Spinal Elements.
In contrast to numerous navigation systems available for spine, FIREFLY does not require upfront capital spend and is single-use and scalable. It features concierge pre-surgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, surgeon-approved pre-selected trajectories, an intraoperative plan and 3D printed patient-specific guides. It is also the only patient-specific pedicle screw guide indicated for use in pediatric patients.
Sources: Mighty Oak Medical, Inc.; FDA.gov; ORTHOWORLD Inc.