Large Compression Screws— 510(k) K262344

Name: FDA 510(k) clearance K262344
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Substantially Equivalent

TriMed, Inc.

FDA 510(k) clearance K262344 for Large Compression Screws, Substantially Equivalent on 2026-08-12. Applicant: TriMed, Inc.. Device class: 2.

Clearance details

Applicant: TriMed, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-07-10
Decision date: 2026-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clarita, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

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K260106 — OsteoCoil GT Active Compression System2026-08-24
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K253108 — VEOFIX Snap Off Screw2026-06-05

More clearances from TriMed, Inc.

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K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)2026-07-16
K261241 — TriMed Compression Screws2026-05-14
K254002 — TriMed Volar Bearing Plates (6 models)2026-01-15
K252061 — Distal Xtremities System2025-08-20
K251134 — RipCord2025-07-11

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.