Class Class II
Arthrex DynaNite Nitinol Staples (K243742)
Description
Arthrex DynaNite Nitinol Staples by Arthrex, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243742
Clearance Date2025-01-31
Clearance TypeTraditional
Product CodeJDR
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243742
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 DynaNite Nitinol Staples (K243742) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023 |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023 |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2020 |
| K172052 | Arthrex DynaNite Nitinol Staple | Arthrex, Inc. | 2017 |
Trace the full predicate network for K243742
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.