Arthrex Humeral Plating System and Cerclage Button— 510(k) K243995

Name: FDA 510(k) clearance K243995
Creator: U.S. Food and Drug Administration
Published: 2025-03-26

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K243995 for Arthrex Humeral Plating System and Cerclage Button, Substantially Equivalent on 2025-03-26. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-12-26
Decision date: 2025-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

More clearances from Arthrex, Inc.

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K262357 — Arthrex Bioabsorbable PushLock Suture Anchors2026-08-07
K260624 — Arthrex Radial Head Replacement System2026-07-30
K260018 — Arthrex FiberButton2026-06-26
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28

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.