Class Class II
Exactech® TRULIANT® Knee System (K240393)
Description
Exactech® TRULIANT® Knee System by Exactech, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240393
Clearance Date2024-10-03
Clearance TypeTraditional
Product CodeMBH
Regulation Number888.3565
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240393
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. Exactech® TRULIANT® Knee System (K240393) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018 |
Trace the full predicate network for K240393
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.