# K162507: Arzzt 3.5 / 4.5 Small & Large Fragments System

- Pathway: 510(k) (Traditional)
- Applicant: Truemed Group, LLC
- Decided: Aug 3, 2017 after 329 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.
3 later devices descend from it; 2 cite it directly.
0 of 16 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 4.

## Most influential descendants
- K182650: Arzzt Distal Radius and Ulna System (2019), 1 descendant of its own
- K200575: Truemed Hand, Foot and Ankle Plates System (2021), 0 descendants of its own
- K172189: Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt (2018), 0 descendants of its own

## Indications for use
The Arzzt 3.5/4.5 Small & Large Fragment Systems is indicated for fixation of fractures, osteotomies, and non-unions of the humerus, radius, ulna, femur, and tibia.

Source page: https://510kreport.com/device/K162507
Methodology: https://510kreport.com/methodology