Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee— 510(k) K222056

Substantially Equivalent

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

FDA 510(k) clearance K222056 for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee, Substantially Equivalent on 2023-01-26. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

Clearance details

Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2022-07-12
Decision date: 2023-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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.