# K251732: Wrist Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies, LLC
- Decided: Feb 12, 2026 after 251 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: 17 generations back to K954385 (1996). 269 ancestors in all.
No later device cites it as a predicate yet.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172170: APTUS (R) Wrist 2.5 System, Medartis AG (2017) Summary page 5.
- K222637: TriMed Wrist Fixation System 3, TriMed, Inc. (2022) Summary page 5.
- K233154: SkyOPS™ Orthopedic Plate System, Sky Surgical, LLC (2023) Summary page 5.
- K233311: Acumed Wrist Plating System, Acumed, LLC (2024) Summary page 5.

## Indications for use
The Wrist Fracture System Distal Radius Plate is indicated for fixation of fractures, osteotomies, and non-unions of the distal radius. The Wrist Fracture System Dorsal Bridge Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.

Source page: https://510kreport.com/device/K251732
Methodology: https://510kreport.com/methodology