C-Stem AMT LE Prosthesis— 510(k) K220216

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K220216 for C-Stem AMT LE Prosthesis, Substantially Equivalent on 2022-07-22. Applicant: Depuy Ireland UC.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2022-01-26
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.