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The Tracker / September 2026 / K262098

510(k) cleared

EnHAnce PEEK Bunion System

Nvision Biomedical Technologies · Sep 18, 2026 · K262098

FDA cleared the EnHAnce PEEK Bunion System from Nvision Biomedical Technologies on Sep 18, 2026 under K262098, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 22, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Nvision Biomedical Technologies has 3 other decisions in the tracker over the last 12 months: K253718 (enHAnce PEEK Bunion System), K260291 (Vortex5 Tailor's Bunion Correction System), K253423 (ToeJack MIS Bunion System).

Questions & Answers

What did FDA clear under K262098?

K262098 is the FDA 510(k) for EnHAnce PEEK Bunion System, submitted by Nvision Biomedical Technologies. FDA's decision date was Sep 18, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the EnHAnce PEEK Bunion System?

Nvision Biomedical Technologies, based in San Antonio, TX, is the applicant of record for K262098.

How long did the K262098 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Sep 18, 2026, 88 days later.

← All decisions in September 2026

Sources