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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 / K260995

510(k) cleared

DynaNail Helix® Fixation System

MedShape, Inc. · Sep 23, 2026 · K260995

FDA cleared the DynaNail Helix® Fixation System from MedShape, Inc. on Sep 23, 2026 under K260995, 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 Mar 26, 2026. The decision came 181 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

MedShape, Inc. has one other decision in the tracker over the last 12 months: K254110 (DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro).

Questions & Answers

What did FDA clear under K260995?

K260995 is the FDA 510(k) for DynaNail Helix® Fixation System, submitted by MedShape, Inc.. FDA's decision date was Sep 23, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the DynaNail Helix® Fixation System?

MedShape, Inc., based in Atlanta, GA, is the applicant of record for K260995.

How long did the K260995 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Sep 23, 2026, 181 days later.

← All decisions in September 2026

Sources