Firebird SI Navigation System

K252088 · Orthofix US, LLC · OLO · Oct 31, 2025 · Neurology

Device Facts

• Record ID: K252088
• Device Name: Firebird SI Navigation System
• Applicant: Orthofix US, LLC
• Product Code: OLO · Neurology
• Decision Date: Oct 31, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Story

Manual surgical instruments (screw driver, drills, inline adapter) used with Medtronic StealthStation Navigation System; utilizes NavLock Tracker and SureTrak II Large Passive Fighter for tracking. System provides real-time, multi-plane 3D/2D visualization of anatomical structures during spinal surgery; assists surgeons in precise placement of Firebird SI Fusion System implants. Used in OR by surgeons for open or minimally invasive procedures. Output consists of visual guidance on navigation display; enables confirmation of hardware placement accuracy; benefits patient through improved surgical precision and reduced invasiveness.

Clinical Evidence

Bench testing only. Engineering analysis performed to demonstrate equivalence in compatibility, accuracy, function, and performance. Biocompatibility evaluation leveraged material and process equivalence to previously cleared devices (K172517 and K211710).

Technological Characteristics

Manual surgical instruments (screw driver, drills, inline adapter) manufactured from stainless steel (ASTM F899 or ASTM A564). Designed for use with Medtronic StealthStation navigation platform. Non-sterile, intended for moist heat sterilization at healthcare facility (SAL 10^-6).

Indications for Use

Indicated for use during spinal surgery for preparation and placement of Firebird SI Fusion System screws in open or minimally invasive procedures; intended for patients requiring stereotactic surgery where rigid anatomical structures (vertebra/pelvis) can be referenced via CT, MR, fluoroscopy, or digitized landmarks.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• SeaSpine Navigation System (K172517)
• StealthStation S8 Spine Software v1.3.0 (K201189)
• Firebird SI Fusion System (K211710)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 31, 2025

Orthofix US LLC
Kendal Moulton
Regulatory Affairs Specialist
3451 Plano Parkway
Lewisville, Texas 75056

Re: K252088
Trade/Device Name: Firebird SI Navigation System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: September 30, 2025
Received: September 30, 2025

Dear Kendal Moulton:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252088 - Kendal Moulton
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252088 - Kendal Moulton
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali

Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252088 | ? |
| Please provide the device trade name(s). | | ? |
| Firebird SI Navigation System | | |
| Please provide your Indications for Use below. | | ? |
| The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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Firebird SI Navigation System
Traditional 510(k)
ORTHOFIX

# 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR § 807.92, the following summary of information is provided:

## A. Submitted by

Kendal Moulton
Regulatory Affairs Specialist
Orthofix US LLC
3451 Plano Parkway, Lewisville TX 75056
[phone]

Date Prepared: October 30th, 2025

## B. Device Name

Tade or Proprietary Name: Firebird SI Navigation System
Common or Usual Name: Orthopedic Stereotaxic Instrument
Classification Name(s): Stereotaxic Instrument
Device Class: Class II
Regulation Number(s): 21 CFR § 882.4560
Product Code(s): OLO

## C. Legally Marketed Predicate Devices

| 510(k) Number | Product Code(s) | Trade Name | Manufacturer |
| --- | --- | --- | --- |
| Primary Predicate | | | |
| K172517 | OLO | SeaSpine Navigation System | SeaSpine Orthopedics Corporation |
| Additional Predicate Device(s) | | | |
| K201189 | OLO | StealthStation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. |
| K211710 | OUR | Firebird SI Fusion System | Orthofix, Inc. |

## D. Device Description

The Firebird SI Navigation System consists of manual, surgical instruments for use with the Medtronic StealthStation Navigation System via the NavLock Tracker and SureTrak II Large Passive Fighter to assist surgeons in locating anatomical structures in minimally invasive and open procedures for preparation and placement of Firebird SI Fusion System implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing

3451 Plano Parkway | Lewisville, TX 75056
214.937.2000
orthofix.com

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Firebird SI Navigation System

Traditional 510(k)

ORTHOFIX

confirmation of hardware placement. The Firebird SI Navigation System instruments are manufactured from Stainless Steel per ASTM F899 or ASTM A564.

The Firebird SI Navigation System instruments include the following:
- Screw Driver
- Drills
- MDT Inline Adapter

The Firebird SI Navigation System instruments are to be used with the following FDA cleared SeaSpine Spinal System:
- Firebird SI Fusion System

# E. Indications for Use

The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

# F. Technological Characteristics

The Firebird SI Navigation System is identical or similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (e.g., design, materials, sterilization, etc.) and performance (mechanical safety).

| Technological Characteristics | Subject Device | Primary Predicate | Additional Predicate | Additional Predicate |
| --- | --- | --- | --- | --- |
| | Firebird SI Navigation System | SeaSpine Navigation System (K172517) | StealthStation S8 Spine Software v1.3. (K201189) | Firebird SI Fusion System (K211710) |
| Navigated System Components | • Drill
• Screw Driver | • Drill
• Screw Driver
• Awl
• Tap
• Probe | • Drill
• Drill Guide
• Screw Driver
• Awl
• Tap
• Probe | N/A |
| SureTrak II Array Attachment Point to Tip Distance | Large Passive Fighter (<260mm) | N/A | Large Passive Fighter (<260mm) | N/A |
| Instrument Materials | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Sterilization | Surgical instruments provided non- | Surgical instruments provided non- | Surgical instruments provided non- | Surgical instruments provided non- |

3451 Plano Parkway | Lewisville, TX 75056

214.937.2000

orthofix.com

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Firebird SI Navigation System
Traditional 510(k)
ORTHOFIX

| | sterile for subsequent moist heat sterilization at health care facility SAL at least 10^{-6} | sterile for subsequent moist heat sterilization at health care facility SAL at least 10^{-6} | sterile for subsequent moist heat sterilization at health care facility SAL at least 10^{-6} | sterile for subsequent moist heat sterilization at health care facility SAL at least 10^{-6} |
| --- | --- | --- | --- | --- |

## G. Performance Data

Engineering analysis demonstrates that the subject Firebird SI Navigation System instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices.

The biocompatibility evaluation leveraged equivalence in materials and manufacturing processes to previously cleared devices (K172517 and K211710) and identical processes to currently manufactured devices. The results of these evaluations show that the subject is substantially equivalent to the cleared predicate.

## H. Conclusion

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Firebird SI Navigation System has been shown to be substantially equivalent to the legally marketed predicate devices.

3451 Plano Parkway | Lewisville, TX 75056
214.937.2000
orthofix.com
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