BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B— 510(k) K043145

Name: FDA 510(k) clearance K043145
Creator: U.S. Food and Drug Administration
Published: 2005-02-18

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K043145 for BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B, Substantially Equivalent on 2005-02-18. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2004-11-15
Decision date: 2005-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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 →

Recalls naming K043145

K-number listed on FDA's recall record

Z-2918-2016 — Arthrex Suture WasherClass III·Terminated·Arthrex, Inc.·20160812

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043145.

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