# K251296: The Acumed Wrist Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jun 18, 2025 after 54 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: 11 generations back to K911837 (1991). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220757: Argo Knotless SP Anchor, Conmed Corporation (2022). Our reading of the summary gave “K220757” beside “510(k)”; FDA’s K220757 is the only number that fits it and carries the summary’s name for the device. Summary page 5.

## 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 is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.

Source page: https://510kreport.com/device/K251296
Methodology: https://510kreport.com/methodology