Class Class II
EXULT Knee Replacement System (K242401)
Description
EXULT Knee Replacement System by Corentec Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242401
Clearance Date2024-09-12
Clearance TypeSpecial
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242401
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EXULT Knee Replacement System (K242401) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024 |
| K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019 |
| K130673 | LOSPA TOTAL KNEE REPLACEMENT SYSTEM | Corentec Co., Ltd. | 2013 |
| K121037 | LOSPA TIBIAL BASE PLATE | Corentec Co., Ltd. | 2012 |
| K110404 | EAUM TOTAL KNEE SYSTEM | Corentec Co., Ltd. | 2012 |
| K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS | Smith & Nephew, Inc. | 2007 |
Trace the full predicate network for K242401
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.