Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

F.A.S.T Screw

K-Number: K254280 · 2026-09-21

ApplicantSteps Ortho
Decision Date2026-09-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

F.A.S.T Screw is the device name listed in this FDA 510(k) record. The listed applicant is Steps Ortho. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K254280. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F.A.S.T Screw?

F.A.S.T Screw is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Steps Ortho. The 510(k) number is K254280.

When did F.A.S.T Screw receive FDA 510(k) clearance?

F.A.S.T Screw received FDA 510(k) clearance on 2026-09-21, under 510(k) number K254280.

Who is the listed applicant for F.A.S.T Screw?

The FDA 510(k) record lists Steps Ortho as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F.A.S.T Screw?

The FDA product code for F.A.S.T Screw is HWC. This falls under the Cardiovascular category.

Other records listing Steps Ortho as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253108VEOFIX Snap Off Screw

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑