F.A.S.T Screw

K254280 · Steps Ortho · HWC · Sep 21, 2026 · Orthopedic

Device Facts

• Record ID: K254280
• Device Name: F.A.S.T Screw
• Applicant: Steps Ortho
• Product Code: HWC · Orthopedic
• Decision Date: Sep 21, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

F.A.S.T® Screws are intended for the fixation of arthrodesis, osteotomies or fractures of bones in the foot and ankle.

Device Story

F.A.S.T.® Screw is a metallic bone fixation fastener system; manufactured from Ti-6Al-4V ELI; available in compression, beveled compression, and neutralization configurations with varying diameters and lengths. Device is used by surgeons in clinical settings to stabilize and attach bones in the foot and ankle to facilitate bone fusion. Implants are placed permanently in the bone. Surgeon selects appropriate screw size based on patient anatomy. Device provides mechanical stabilization of bone segments; benefits include support for healing of fractures, osteotomies, or arthrodesis sites.

Clinical Evidence

Bench testing only. Mechanical/functional testing included pullout strength, driving/removal torque, and torsional resistance. Biocompatibility evaluated per ISO 10993-1 and ISO 14971. Sterilization validated per ISO 11137-1. Pyrogenicity tested per ANSI/AAMI ST72. MR compatibility evaluated and determined to be MR Conditional.

Technological Characteristics

Material: Ti-6Al-4V ELI (ISO 5832-3). Principle: Metallic bone fixation fastener. Form factor: Compression, beveled compression, and neutralization screws in various diameters (2.3mm–6.5mm). Sterilization: Radiation (ISO 11137-1). MR status: MR Conditional.

Indications for Use

Indicated for fixation of arthrodesis, osteotomies, or fractures of bones in the foot and ankle.

Regulatory Classification

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.

Predicate Devices

• I.B.S (K160174, K131920, K170594, K231236)

Submission Summary (Full Text)

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September 21, 2026

Steps Ortho
% Christine Scifert
Partner
MRC Global, LLC
9160 Hwy 64, Suite 12
P.O. Box 330
Lakeland, Tennessee 38002

Re: K254280

Trade/Device Name: F.A.S.T Screw
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: HWC
Dated: August 20, 2026
Received: August 21, 2026

Dear Christine Scifert:

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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K254280 - Christine Scifert

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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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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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 -S

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. | K254280 | ? |
| Please provide the device trade name(s). | | ? |
| F.A.S.T Screw | | |
| Please provide your Indications for Use below. | | ? |
| F.A.S.T® Screws are intended for the fixation of arthrodesis, osteotomies or fractures of bones in the foot and ankle. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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STEPS

ORTHO

F.A.S.T.® Screw – Traditional 510(k)

# 510(k) Summary

Prepared:

I. SUBMITTER

a. Company :

STEPS ORTHO

3, allée des Ginkgos

69500 BRON - FRANCE

Phone: [phone]

Contact: Morgane GRENIER

Quality and Regulatory Affairs Director

Phone: + 33 (0) 4 28 89 81 15

e-mail: [e-mail]

b. Primary Correspondent :

MRC Global, LLC

Christine Scifert

Partner

Phone : [phone]

e-mail : [e-mail]

II. DEVICE

Name of Device:

F.A.S.T.® Screw

Common/Usual Name:

Screw, Fixation, Bone

Regulation Numbers:

21 CFR 888.3040

Regulation Name:

Smooth or threated metallic bone fixation fastener

Regulatory Class:

II

Product Codes:

HWC, Screw, fixation, bone

III. PREDICATE DEVICE

Primary Predicate

I.B.S (K160174, K131920, K170594, K231236)

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STEPS ORTHO

F.A.S.T.® Screw – Traditional 510(k)

# IV. DEVICE DESCRIPTION

The F.A.S.T.® Screw implants are manufactured in Ti-6Al-4V ELI (the composition is compliant with ISO 5832-3 standard).

The range is made of 3 type of screws “Compression”, “Neutralisation” and “Beveled compression” screws.

F.A.S.T® screws are available in different diameters and lengths :

- F.A.S.T® Compression screws, are available in diameters 2.3mm, 2.7mm, 3.2mm, 4.2mm and 6.5mm;
- F.A.S.T® Beveled compression screws, are available in diameters 2.7mm, 3.2mm and 6.5mm;
- F.A.S.T® Neutralization screws, are available in diameters 2.7mm and 6.5mm.

# V. INDICATIONS FOR USE

F.A.S.T® Screws are intended for the fixation of arthrodesis, osteotomies or fractures of bones in the foot and ankle.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject device F.A.S.T.® Screw and the predicate device are implants intended for fixation of arthrodesis, osteotomies or fractures of bones. F.A.S.T.® Screw is very similar to the predicate device in terms of technological characteristics. Specifically, both devices are composed of Ti-6Al-4V ELI and are placed permanently in the bones. The differences in sizes and diameters of the implants do not raise new types of questions of safety or effectiveness either, as the key question remains to be whether the devices can accommodate the size variation of bones across the patient population. Both devices are designed to offer the surgeon to accommodate individual patient anatomy. The key questions of safety and effectiveness for both devices are the same, i.e., whether the implant can be correctly implanted, whether the implant can perform the stabilization and attachment of the bones to each other to achieve bone fusion. In addition, bench testing confirms that the technical characteristics of F.A.S.T.® Screw is appropriate for its intended use and functions as intended. Thus, a conclusion of substantial equivalence is supported.

# VII. PERFORMANCE TESTING

The following performance testing was conducted to support substantial equivalence:

# Performance Testing

Mechanical and functional testing was performed to verify the design of the implant, including:

- Pullout strength
- Driving and removal torque
- Torsional resistance

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STEPS ORTHO

F.A.S.T.® Screw – Traditional 510(k)

# Biocompatibility

Biocompatibility testing was conducted in accordance with NF EN ISO 10993-1: 2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and NF EN ISO 14971: 2019 Medical devices - Application of risk management to medical devices.

# Sterility

Sterilization validation testing was performed in accordance with NF EN ISO 11137-1: 2016 “Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.”

# Pyrogenicity

Endotoxin testing was completed per ANSI / AAMI ST72.

Routine tests are done quarterly based on Cleaning subcontractor risk analysis.

# MR Compatibility

F.A.S.T® Screw has been evaluated for safety in the magnetic resonance environment and has been determined to be MR Conditional.

STEPS ORTHO implant can be scanned safely after implantation under specific conditions mentioned in the Instructions for Use.

# VIII. CONCLUSIONS

The differences that exist between F.A.S.T.® Screw and its predicate do not raise different questions of safety or effectiveness. The results of performance testing demonstrate that F.A.S.T.® Screw will perform safely as intended and support a determination of substantial equivalence to the predicate device which is marketed for the same intended use.

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