AGILON® XO Shoulder Replacement System— 510(k) K241944

Substantially Equivalent

Implantcast GmbH

FDA 510(k) clearance K241944 for AGILON® XO Shoulder Replacement System, Substantially Equivalent on 2025-03-10. Applicant: Implantcast GmbH.

Clearance details

Applicant: Implantcast GmbH
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2024-07-02
Decision date: 2025-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buxtehude, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.