Class Class II
The Acumed Wrist Fixation System – 2.4mm Screws (K252356)
Description
The Acumed Wrist Fixation System - 2.4mm Screws by Acumed, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252356
Clearance Date2025-08-21
Clearance TypeSpecial
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252356
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. The Acumed Wrist Fixation System – 2.4mm Screws (K252356) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist... | Acumed, LLC | 2025 |
Trace the full predicate network for K252356
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.