# K250472: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

- Pathway: 510(k) (Traditional)
- Applicant: Amdt Holdings, Inc.
- Decided: Aug 8, 2025 after 171 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: 15 generations back to K962616 (1996). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS), Arrowhead De, LLC (2019) Summary page 5.

## Indications for use
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is intended to be used for posttraumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions. The SixFix™ web application for the DACS software can be used with the SixFix™ Hexapod fixator. Use of the software is optional for clinicians using the SixFix™ Hexapod fixator.

Source page: https://510kreport.com/device/K250472
Methodology: https://510kreport.com/methodology