EXULT Knee Replacement System— 510(k) K242401

Substantially Equivalent

Corentec Co., Ltd.

FDA 510(k) clearance K242401 for EXULT Knee Replacement System, Substantially Equivalent on 2024-09-12. Applicant: Corentec Co., Ltd..

Clearance details

Applicant: Corentec Co., Ltd.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2024-08-13
Decision date: 2024-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Chungchongnam-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.