Class Class II
Linkt Compression Staple System (K250712)
Description
Linkt Compression Staple System by Trax Surgical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250712
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeJDR
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250712
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. Linkt Compression Staple System (K250712) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023 |
| K203832 | FuseForce Flex Dynamic Compression System | Wright Medical | 2021 |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021 |
Trace the full predicate network for K250712
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.