# K233311: Acumed Wrist Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Apr 22, 2024 after 206 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: 5 generations back to K000684 (2000). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 4.
- K120903: Congruent Bone Plate System: Acu-Loc 2 Plate, Acumed, LLC (2012) Summary page 4.
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 4.

## Most influential descendants
- K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (2025), 1 descendant of its own
- K251732: Wrist Fracture 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
Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.

Source page: https://510kreport.com/device/K233311
Methodology: https://510kreport.com/methodology