# K181528: Austin Miller Large External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Austin Miller Trauma, LLC
- Decided: Feb 28, 2019 after 262 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: 4 generations back to K994143 (2000). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082650: Synthes Large External Fixation, MR Conditional, Synthes (Usa) (2008) Summary page 4.
- K090658: Synthes External Fixation Devices, MR Conditional, Synthes (Usa) (2010) Summary page 4.
- K113383: Xtrafix External Fixation System, Extraortho, Inc. (2012) Summary page 4.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 4.

## Most influential descendants
- K213874: MAVERICK External Fixation System (2022), 1 descendant of its own
- K223112: MAVERICK Mini External Fixation System (2022), 0 descendants of its own

## Indications for use
The Austin Miller External Fixation System is intended to be used on adult or pediatric patients for stabilization of the long bones, feet, and pelvis. The most common indication is for stabilization of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.

Source page: https://510kreport.com/device/K181528
Methodology: https://510kreport.com/methodology