# K100123: Acumed Wrist Arthrodesis Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Oct 6, 2010 after 264 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: 3 generations back to K915818 (1992). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 2.
- K023879: Small Titanium Wrist Fusion Plate, Synthes (Usa) (2003) Summary page 2.
- K011458: Synthes Straight Wrist Fusion Plate, 170MM, Synthes (Usa) (2001) Summary page 2.
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 2.
- K052754: Wrist Fusion Plate, Dvo Extremity Solutions, LLC (2005) Summary page 2.
- K991873: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 2.

## Most influential descendants
- K131380: Acumed Totalw Rist Fusion Plating System (2013), 0 descendants of its own

## Indications for use
The Acumed Wrist Arthrodesis Plate System is intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.

Source page: https://510kreport.com/device/K100123
Methodology: https://510kreport.com/methodology