GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert— 510(k) K173875

Substantially Equivalent

Stelkast, Inc.

FDA 510(k) clearance K173875 for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert, Substantially Equivalent on 2018-01-19. Applicant: Stelkast, Inc..

Clearance details

Applicant: Stelkast, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2017-12-21
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Special
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.