Airlock® Ankle Plating System— 510(k) K260274

Name: FDA 510(k) clearance K260274
Creator: U.S. Food and Drug Administration
Published: 2026-03-25

Substantially Equivalent

Novastep SAS

FDA 510(k) clearance K260274 for Airlock® Ankle Plating System, Substantially Equivalent on 2026-03-25. Applicant: Novastep SAS. Device class: 2.

Summary

Novastep SAS's Airlock® Ankle Plating System is filed under HRS, bone fixation plates. The record doesn't list plate sizes or components.

Class II, 21 CFR 888.3030. It was an Abbreviated 510(k), and Orthopedic is both the classification panel and the review panel.

Novastep filed from Rennes, France. The decision came 55 calendar days after FDA received it (January 29 to March 25, 2026).

Clearance details

Applicant: Novastep SAS
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-01-29
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rennes, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K263602 — Arthrex Plates, Screws and Pins, and Washers2026-10-29
K261135 — Trochlear Salvage Plating System2026-10-26
K262779 — ANTHEM Fracture System2026-10-23
K263407 — Tempo Plating System2026-10-23
K263269 — Park's Pectus System2026-10-15

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.