ENDURO KNEE SYSTEM— 510(k) K101815

Substantially Equivalent

Aesculap Implant Systems

FDA 510(k) clearance K101815 for ENDURO KNEE SYSTEM, Substantially Equivalent on 2010-12-20. Applicant: Aesculap Implant Systems.

Clearance details

Applicant: Aesculap Implant Systems
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2010-06-30
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.