Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System— 510(k) K150544

Substantially Equivalent

Aesculap Implant Systems, LLC

FDA 510(k) clearance K150544 for Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System, Substantially Equivalent on 2015-05-29. Applicant: Aesculap Implant Systems, LLC.

Clearance details

Applicant: Aesculap Implant Systems, LLC
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2015-03-03
Decision date: 2015-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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.