# K133166: Ins Hilden Tibial Arzzt

- Pathway: 510(k) (Traditional)
- Applicant: Truemed Group, LLC
- Decided: Nov 6, 2014 after 385 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: 1 generation back to K914453 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 4.
- K932330: TI-6AL-7NB Urtn, Synthes (Usa) (1996) Summary page 4.

## Most influential descendants
- 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
Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.

Source page: https://510kreport.com/device/K133166
Methodology: https://510kreport.com/methodology