# K182650: Arzzt Distal Radius and Ulna System

- Pathway: 510(k) (Traditional)
- Applicant: Truemed Group, LLC
- Decided: Jun 10, 2019 after 259 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 K981372 (1998). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 4.
- K082072: Synthes (Usa) 3.5MM LCP Hook Plate, Synthes (Usa) (2008) Summary page 4.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 4.
- K162507: Arzzt 3.5 / 4.5 Small & Large Fragments System, Truemed Group, LLC (2017) Summary page 4.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.

## Most influential descendants
- K200575: Truemed Hand, Foot and Ankle Plates System (2021), 0 descendants of its own

## Indications for use
The Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Source page: https://510kreport.com/device/K182650
Methodology: https://510kreport.com/methodology