# K052754: Wrist Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Dvo Extremity Solutions, LLC
- Decided: Oct 27, 2005 after 27 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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: 1 generation back to K000558 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- K100123: Acumed Wrist Arthrodesis Plate System (2010), 1 descendant of its own
- K131380: Acumed Totalw Rist Fusion Plating System (2013), 0 descendants of its own

## Indications for use
For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. 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. This single use device is for cementless use only.

Source page: https://510kreport.com/device/K052754
Methodology: https://510kreport.com/methodology