Class Class II
Arthrex Intramedullary Nails (K243890)
Description
Arthrex Intramedullary Nails by Arthrex, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243890
Clearance Date2025-01-13
Clearance TypeSpecial
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243890
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. Arthrex Intramedullary Nails (K243890) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233134 | I.T.S. INS Proximal Femur Nail | I.T.S. GmbH | 2024 |
| K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 |
| K132217 | ARTHREX COMPRESSION FT SCREWS | Arthrex, Inc. | 2013 |
Trace the full predicate network for K243890
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.