Catalyst F1x Shoulder System— 510(k) K252418

Substantially Equivalent

Catalyst Orthoscience, Inc.

FDA 510(k) clearance K252418 for Catalyst F1x Shoulder System, Substantially Equivalent on 2025-11-06. Applicant: Catalyst Orthoscience, Inc..

Clearance details

Applicant: Catalyst Orthoscience, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2025-08-01
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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.