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Firefly Pedicle Screw Navigation Guide

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162419

by Mighty Oak Medical, Inc.

Identifiers

510(k) Number
K162419 FDA 510(k)
FDA Product Code
PQC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Firefly Pedicle Screw Navigation Guide is a patient-specific, 3D-printed orthopedic device designed to assist in the precise placement of pedicle screws during spinal surgery. Classified as a Pedicle Screw Placement Guide, it aids surgeons in achieving accurate screw trajectory, reducing the risk of misplacement and improving procedural outcomes in orthopedic applications.

This guide is used intraoperatively in the operating room and is supplied as a custom, single-use device per patient case. It is compatible with metallic instrument sleeves and OEM taps, allowing controlled advancement of drilling instruments to the surgeon’s desired depth. The device is regulated under FDA 510(k) clearance (K162419) and falls under Class II medical device classification for orthopedic use, with no noted MRI safety restrictions in the available data.

Frequently asked questions

What is the primary purpose of the Firefly Pedicle Screw Navigation Guide during spinal surgery?

The Firefly Pedicle Screw Navigation Guide is designed to assist surgeons in achieving precise placement of pedicle screws during spinal procedures. By providing a patient-specific, 3D-printed guide, it helps reduce the risk of screw misplacement, ensuring accurate trajectory and improving surgical outcomes in orthopedic applications.

Is the Firefly Pedicle Screw Navigation Guide reusable or intended for single-use per patient?

The Firefly Pedicle Screw Navigation Guide is supplied as a custom, single-use device per patient case. This design ensures sterility and reduces the risk of cross-contamination between procedures, as it is intended for intraoperative use in the operating room.

What compatibility features does the Firefly Pedicle Screw Navigation Guide offer for surgical instruments?

The guide is compatible with metallic instrument sleeves and OEM taps, allowing controlled advancement of drilling instruments to the surgeon’s desired depth. This compatibility ensures seamless integration with existing surgical tools during pedicle screw placement.

How is the Firefly Pedicle Screw Navigation Guide regulated, and what class does it fall under?

The Firefly Pedicle Screw Navigation Guide is regulated under FDA 510(k) clearance (K162419) and is classified as a Class II medical device for orthopedic use. The clearance was granted under the Traditional 510(k) review pathway, with a decision of 'Substantially Equivalent' to predicate devices.

Are there any special storage or handling requirements for the Firefly Pedicle Screw Navigation Guide?

Since the guide is a custom, single-use device, it is not pre-packaged for general storage. However, as a sterile, intraoperative tool, it should be handled according to standard surgical instrument protocols—typically stored in a clean, dry environment until use, then disposed of post-procedure to maintain sterility and compliance with medical device regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF FIREFLY PEDICLE SCREW NAVIGATION GUIDE - Tekno Surgical, FIREFLY® - Mighty Oak Medical, RESOURCES - Mighty Oak Medical, FIREFLY® Pedicle Screw Navigation Guide (K181399) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mighty Oak Medical, Inc.

Sources (1)

  • FDA 510(k) K162419 24 fields · synced Oct 6, 2026