Mighty Oak Medical receives FDA clearance for new 3D-printed navigation guide: 3 notes

Shayna Korol | July 26, 2018

Mighty Oak Medical received FDA 510(k) clearance for its patient-specific, 3D-printed S2AI Guide for sacroiliac fixation in complex spinal reconstruction.

Here are three things to know:

1. The company’s Firefly Pedicle Screw Navigation Guides, including the S2AI Guide, do not require intraoperative fluoroscopy.

2. Firefly Guides feature presurgical planning, an autoclavable bone model, predetermined screw sizing, an intraoperative digital plan and 3D-printed patient-specific guides to mechanically constrain the drill and tap to follow the preselected trajectories.

3. Firefly Guides are open platform and compatible with all pedicle screw systems.

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