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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K254280

510(k) cleared

F.A.S.T Screw

Steps Ortho · Sep 21, 2026 · K254280

FDA cleared the F.A.S.T Screw from Steps Ortho on Sep 21, 2026 under K254280, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 30, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Steps Ortho has one other decision in the tracker over the last 12 months: K253108 (VEOFIX Snap Off Screw).

Questions & Answers

What did FDA clear under K254280?

K254280 is the FDA 510(k) for F.A.S.T Screw, submitted by Steps Ortho. FDA's decision date was Sep 21, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the F.A.S.T Screw?

Steps Ortho, based in Bron, is the applicant of record for K254280.

How long did the K254280 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Sep 21, 2026, 265 days later.

← All decisions in September 2026