Class Class II
BKS Revision System (K242984)
Description
BKS Revision System by Ortho Development Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242984
Clearance Date2024-10-25
Clearance TypeSpecial
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242984
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. BKS Revision System (K242984) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181569 | BKS Revision Sleeves System | Ortho Development Corporation | 2018 |
Trace the full predicate network for K242984
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.