The Acumed Wrist Fixation System - 2.4mm Screws— 510(k) K252356

Name: FDA 510(k) clearance K252356
Creator: U.S. Food and Drug Administration
Published: 2025-08-21

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K252356 for The Acumed Wrist Fixation System - 2.4mm Screws, Substantially Equivalent on 2025-08-21. Applicant: Acumed, LLC. Device class: 2.

Clearance details

Applicant: Acumed, LLC
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-07-29
Decision date: 2025-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hillsboro, OR, US

Download summary PDF View on FDA.gov ↗

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K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

More clearances from Acumed, LLC

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K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws2025-07-14
K251296 — The Acumed Wrist Fixation System2025-06-18
K243624 — Acu-Sinch Knotless Mini2025-01-23
K233311 — Acumed Wrist Plating System2024-04-22
K230744 — Acumed Acutrak 3 Headless Compression Screw System2023-06-09

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.