# K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

- Pathway: 510(k) (Abbreviated)
- Applicant: Acumed, LLC
- Decided: Jul 14, 2025 after 94 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000684 (2000). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233311: Acumed Wrist Plating System, Acumed, LLC (2024) Summary page 5.
- K131764: Acumed Wrist Spanning Plate, Acumed, LLC (2013) Summary page 5.

## Most influential descendants
- K252356: The Acumed Wrist Fixation System - 2.4mm Screws (2025), 0 descendants of its own

## Recalls of this device
- May 28, 2026 · Class II · Z-2532-2026: Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

## Indications for use
The Indications for Use for The Acumed Wrist Fixation System / Plates, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna. The Indications for Use for The Acumed Wrist Fixation System/ Screws, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.

Source page: https://510kreport.com/device/K251132
Methodology: https://510kreport.com/methodology