MyShoulder Planner (5.3SSWPL)— 510(k) K241292

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K241292 for MyShoulder Planner (5.3SSWPL), Substantially Equivalent on 2025-01-30. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2024-05-08
Decision date: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

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.