# K172189: Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt

- Pathway: 510(k) (Traditional)
- Applicant: Truemed Group, LLC
- Decided: Jan 16, 2018 after 180 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133166: Ins Hilden Tibial Arzzt, Truemed Group, LLC (2014) Summary page 4.
- K033878: Ace Antegrade Retrograde Humeral Nail System, Depuy Ace (2004) Summary page 4.
- K032097: Depuy Ace Versanail Tibial Nail, DePuy Orthopaedics, Inc. (2003) Summary page 4.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 4.
- K162507: Arzzt 3.5 / 4.5 Small & Large Fragments System, Truemed Group, LLC (2017). Cleared while this submission was under review Summary page 4.

## Indications for use
Ins Hilden Arzzt Nail Systems, consisting of intramedullary solid and cannulated nails, end cap and locking screws, are intended for fixation of fractures of different types: of the shaft, open and closed shaft fractures; and malunion and non-unions of the Femur, Tibia, and Humerus.

Source page: https://510kreport.com/device/K172189
Methodology: https://510kreport.com/methodology