Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)— 510(k) K151500

Name: FDA 510(k) clearance K151500
Creator: U.S. Food and Drug Administration
Published: 2015-10-05

Substantially Equivalent

Custom Orthopaedic Solutions

FDA 510(k) clearance K151500 for Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS), Substantially Equivalent on 2015-10-05. Applicant: Custom Orthopaedic Solutions. Device class: 2.

Clearance details

Applicant: Custom Orthopaedic Solutions
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2015-06-04
Decision date: 2015-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.

Clearance details

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Adverse events under product code KWS