EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM— 510(k) K122883

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K122883 for EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM, Substantially Equivalent on 2013-08-05. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2012-09-20
Decision date: 2013-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcmurray, PA, US

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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.