# K162032: Arrowhead Mini-Rail Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Arrowhead De, LLC
- Decided: Feb 21, 2017 after 214 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 9 generations back to K962823 (1996). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080071: Sidekick Rail Fixator, Wrightmedicaltechnologyinc (2008) Summary page 5.
- K121004: Apex Kirschner Wires and Steinmann Pins, Apex Tools & Orthopedics Co. (2012) Summary page 5.
- K150661: ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite, Citieffe S.R.L. (2015) Summary page 5.

## Most influential descendants
- K252106: External Fixation Mini Rail System (2025), 0 descendants of its own

## Indications for use
The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

Source page: https://510kreport.com/device/K162032
Methodology: https://510kreport.com/methodology