The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The Frontier Devices FUSIO Screw Fuze System consists of titanium bone screws of 7mm, 9.5mm, and 11mm diameter of various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw. The screws are made from titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

AI/ML Overview

The provided document describes the Frontier Devices FUSIO Screw Fuze System, a medical device for sacroiliac joint fusion. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Instead, the "acceptance criteria" here relate to demonstrating that the new device performs similarly in mechanical tests to legally marketed predicate devices, thereby meeting the FDA's requirements for 510(k) clearance.

Here’s a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance
Insertion Torque:	FUSIO Screw Fuze System:
- Comparable insertion torque to predicate screws.	- Tests showed "similar results as predicate screws" (Globus and X-Spine) into Grade 15 polyurethane foam blocks. Peak torque measured after 4 revolutions was recorded and compared using mean torque values with standard deviations. "The insertion torque measurements... support the fact that the Frontier Devices FUSIO Screw Fuze System screws are substantially equivalent to predicate screws."
Mechanical Properties (Cross-Sectional):	FUSIO Screw Fuze System:
- Comparable ability to handle forces and stresses.	- Engineering analysis (using SolidWorks) of the worst-case FUSIO Screw Fuze screw at the cross-section (middle of the screw) determined it could "handle forces and associated stresses similarly" to the legally marketed X-Spine Silex screw.
Thread Properties (Projected Thread Engagement Area):	FUSIO Screw Fuze System:
- Comparable thread engagement area.	- SolidWorks was used to calculate the projected threaded area, showing "substantial equivalence" to the predicate devices.
Cyclic Bending Endurance:	FUSIO Screw Fuze System:
- Meet pass-fail criteria for endurance under cyclic loading.	- Cyclic bending tests on the worst-case FUSIO Screw Fuze screw produced an endurance curve "which yielded acceptable factors of safety for the force and moment." The system "successfully passed the pass-fail criteria."
Material Composition:	FUSIO Screw Fuze System:
- Made from titanium alloy (ASTM F136).	- The screws are made from titanium alloy, Ti-6Al-4V, conforming to ASTM F136. This is consistent with predicate devices.
Dimensions (Diameter and Length):	FUSIO Screw Fuze System:
- Similar diameters and lengths.	- Available in 7mm, 9.5mm, and 11mm diameters of various lengths, which are "similar to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of individual screws tested for each assessment (insertion torque, cyclic bending). The document mentions "representative screws" for insertion torque and "the worst-case FUSIO Screw Fuze screw" for engineering analysis and cyclic bending tests. This suggests a limited number of physical samples for mechanical testing, characteristic of device design verification.
Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory mechanical testing of the FUSIO Screw Fuze System and comparative measurements/analyses against predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This question is not applicable to this type of device submission. There is no "ground truth" to be established by medical experts for mechanical performance tests of bone screws. The "ground truth" here is the objective physical measurement of mechanical properties.

4. Adjudication Method

Not applicable. There is no adjudication required for laboratory mechanical test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a mechanical device, not an imaging or diagnostic AI device. MRMC studies are not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (bone screw), not an algorithm or AI.

7. The Type of Ground Truth Used

Objective Mechanical Measurements and Engineering Analysis: The "ground truth" for the performance tests consists of:
- Direct physical measurements (e.g., peak insertion torque, force sustained during cyclic loading).
- Engineering calculations and simulations (e.g., stress analysis using SolidWorks, projected threaded area).
- Comparison against established ASTM standards (ASTM F136 for material).
- Comparison against the known performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set. The design of the device would be informed by engineering principles, material science, and the existing predicate devices.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

Folsom Metal Products, Inc. DBA Frontier Devices Mr. Kevin Etheridge Director of Engineering 153 A Cahaba Valley Parkway Pelham, Alabama 35124

Re: K141106

Trade/Device Name: Frontier Devices FUSIO Screw Fuze System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: Class II Product Code: OUR Dated: May 30, 2014 Received: August 6, 2014

Dear Mr. Etheridge:

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 (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. 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.

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 803); good manufacturing practice requirements as set

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Page 2 – Mr. Kevin Etheridge

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Pg.1/1

510(k) Number (if known) K141106

Device Name

Frontier Devices FUSIO Screw Fuze System

Indications for Use (Describe)

The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5 510k Summary

The following information is provided as required by 21 CFR 807.87 for the 510(k) premarket notification for the bone screw system, Frontier Devices FUSIO Screw Fuze System.

Date Prepared:	October 07, 2014
Sponsor :	Frontier Devices153A Cahaba Valley ParkwayPelham, AL 35124
FDA Registration #:	1065595
Contact Person:	Kevin EtheridgeDirector of Engineering205-733-0901 (phone)205-733-8445 (fax)kevin@frontierdevices.com
Proprietary Names:	Frontier Devices FUSIO Screw Fuze System
Common Names:	Bone screws
Classification Names:RegulatoryProduct Code	Smooth or threaded metallic bone fixation fastenersClass IIOUR888.3040
Device Classification:	Class II
Predicate Devices:	Globus Medical SI -Lok Sacroiliac Joint Fixation System (K112028)Silex Sacroiliac Joint Fusion System (K123702)
Device Descriptions:	Frontier Devices FUSIO Screw Fuze SystemThe Frontier Devices FUSIO Screw Fuze System consists of titanium bone screws of7mm, 9.5mm, and 11mm diameter of various lengths to accommodate patientanatomy. An optional serrated washer can be placed on the screw. The screws are madefrom titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.
Indications for Use:	The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliacjoint fusion for conditions including sacroiliac joint disruptions and degenerativesacroiliitis.

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Technology The screws of the Frontier Devices FUSIO Screw Fuze System have characteristics, similar dimensions, designs and materials as the predicate devices. The screws are all made from titanium alloy (ASTM F136) with diameters and lengths which are similar to the predicate devices.

Performance Tests: Performance tests on representative FUSIO Screw Fuze screws to have similar results as predicate screws. Tests measuring the insertion torque for representative screws of Frontier Devices FUSIO Screw Fuze System and predicate devices (Globus and X-Spine) into Grade 15 polyurethane foam blocks were conducted. The screws were inserted into the foam block and the peak torque was measured after 4 revolutions. The results were recorded and compared using mean torque values with standard deviations. The insertion torque measurements from the tests support the fact that the Frontier Devices FUSIO Screw Fuze System screws are substantially equivalent to predicate screws.

An engineering analysis was performed to show that the worst case Frontier Devices FUSIO Screw Fuze screw is substantially equivalent than the legally marketed X-Spine Silex screw predicate device. Using Solidworks, the screws were analyzed at the crosssection, more specifically at the middle of the screw, in order to determine if the screws would handle forces and associated stresses similarly. SolidWorks was also used to calculate the projected threaded area for forming a comparison of the projected thread engagement area for the FUSIO Screw Fuze screws and the predicate devices. In all areas studied, including overall sizes and materials, cross sectional mechanical properties, and thread properties, the FUSIO Screw Fuze results were substantially equivalent to those of the predicate device.

Cyclic bending tests were performed on the worst case FUSIO Screw Fuze screw design to verify the mechanical characteristics of the screw. Research was performed to determine the average forces and moments seen in the sacroiliac joint and to determine the number of "cycles" to use for testing. An endurance curve of the worst case screw was produced through mechanical testing, which yielded acceptable factors of safety for the force and moment. Based on the cyclic loading test results, the FUSIO Screw Fuze successfully passed the pass-fail criteria.

Substantial Equivalence: The Frontier Devices FUSIO Screw Fuze System consists of screws that are similar in material composition and have the same indications for use as the predicate device. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate device. There may be slight differences in dimensions and shapes between the Frontier Devices FUSIO Screw Fuze System and the predicate device; however, these minor differences raise no new issues of safety and efficacy of the devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.