# K252356: The Acumed Wrist Fixation System - 2.4mm Screws

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Aug 21, 2025 after 23 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K000684 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws, Acumed, LLC (2025) Summary page 4.

## Indications for use
The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System.

Source page: https://510kreport.com/device/K252356
Methodology: https://510kreport.com/methodology