Arthrex Sterile VAL and VAL KreuLock Compression Screw System— 510(k) K260809

Name: FDA 510(k) clearance K260809
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K260809 for Arthrex Sterile VAL and VAL KreuLock Compression Screw System, Substantially Equivalent on 2026-06-25. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-03-12
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22
K253108 — VEOFIX Snap Off Screw2026-06-05

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
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28
K254215 — Arthrex Beaming System2026-05-08

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.