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The Tracker / October 2026 / K261961

510(k) cleared

Ntegrate Threaded Nail System

Nvision Biomedical Technologies · Oct 14, 2026 · K261961

FDA cleared the Ntegrate Threaded Nail System from Nvision Biomedical Technologies on Oct 14, 2026 under K261961, 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 Jun 11, 2026. The decision came 125 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nvision Biomedical Technologies has 4 other decisions in the tracker over the last 12 months: K262098 (EnHAnce PEEK Bunion System), K253718 (enHAnce PEEK Bunion System), K260291 (Vortex5 Tailor's Bunion Correction System), K253423 (ToeJack MIS Bunion System).

Questions & Answers

What did FDA clear under K261961?

K261961 is the FDA 510(k) for Ntegrate Threaded Nail System, submitted by Nvision Biomedical Technologies. FDA's decision date was Oct 14, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the Ntegrate Threaded Nail System?

Nvision Biomedical Technologies, based in San Antonio, TX, is the applicant of record for K261961.

How long did the K261961 review take?

FDA received the submission on Jun 11, 2026 and issued its decision on Oct 14, 2026, 125 days later.

← All decisions in October 2026

Sources