OrthoPediatrics Announces Expanded Indication for FIREFLY Pedicle Screw Navigation

By Julie A. Vetalice

OrthoPediatrics announced an additional FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide to include S2AI screw trajectory for sacral-iliac fixation in complex spinal reconstruction.

OrthoPediatrics has served as the exclusive U.S. distributor for Mighty Oak Medical's navigation system for just under one year. FIREFLY can be used with any spinal deformity correction system, including OrthoPediatrics' RESPONSE scoliosis technology.

The guides are 3D-printed, disposable and patient-specific, and present an alternative to complex, radiation-emitting navigation systems during long surgical procedures. Further, they are reportedly the only patient-specific pedicle screw guide indicated for use in pediatric patients.

Sources: OrthoPediatrics Corp.; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory