FIREFLY® Pedicle Screw Navigation Guide

The FIREFLY® Pedicle Screw Navigation Guide is a patient-specific surgical guide that assists in accurate placement of pedicle screws during non-cervical open posterior spinal fixation procedures (T1-S2/S2AI and ilium). It uses anatomical landmarks from preoperative imaging to guide surgical instruments along presurgically planned trajectories to create pilot holes for pedicle screw insertion. The device consists of single-use patient-specific components and reusable non-patient-specific components, and is intended for single use only.

The device possesses the same technological characteristics as the predicate device including performance, manufacturing process, sterilization, biocompatible materials, and basic design. The primary difference is the addition of MRI-Derived Synthetic CT imaging data as an input modality, whereas the predicate device used only CT scans. Patient-specific components are manufactured using additive manufacturing (stereolithography or multi-jet fusion systems), and non-patient-specific components use biocompatible materials per ASTM F899 or F136.

Materials for non-patient-specific components are manufactured in accordance with ASTM F899 or F136. The device is subject to Quality Management System Regulation (QMSR) requirements including ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action).

The FIREFLY® Pedicle Screw Navigation Guide is substantially equivalent to predicate K181399 because it possesses the same intended use, technological characteristics, and basic design. The sole difference—expansion to accept MRI-Derived Synthetic CT imaging data as an input—was validated through quantitative and qualitative studies (segmentation output comparison, presurgical plan comparison, and MRI-derived sCT qualification) demonstrating equivalent performance to CT-only inputs. All guides T1-S2/S2AI and ilium remain unchanged in form, fit, and function from the predicate.