VEGA KNEE SYSTEM— 510(k) K121879

Substantially Equivalent

Aesculap Implant Systems

FDA 510(k) clearance K121879 for VEGA KNEE SYSTEM, Substantially Equivalent on 2012-07-27. Applicant: Aesculap Implant Systems.

Clearance details

Applicant: Aesculap Implant Systems
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2012-06-28
Decision date: 2012-07-27
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.