# K131764: Acumed Wrist Spanning Plate

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Sep 5, 2013 after 80 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: 4 generations back to K981372 (1998). 12 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 2.

## Most influential descendants
- K191848: APTUS Wrist Spanning Plates 2.5 (2019), 2 descendants of its own
- K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (2025), 1 descendant of its own
- K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (2024), 1 descendant of its own
- K261351: SALGINA 2.5mm Distal Radius System (2026), 0 descendants of its own
- K252356: The Acumed Wrist Fixation System - 2.4mm Screws (2025), 0 descendants of its own

## Indications for use
The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.

Source page: https://510kreport.com/device/K131764
Methodology: https://510kreport.com/methodology