# K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

- Pathway: 510(k) (Traditional)
- Applicant: Arrowhead De, LLC
- Decided: May 14, 2019 after 119 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: 14 generations back to K962616 (1996). 61 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 5.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 5.
- K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation, Arrowhead Medical Device Technologies, LLC (2018) Summary page 5.
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 5.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 5.

## Most influential descendants
- K253764: ENOS Software Guided External Fixation System (2026), 0 descendants of its own
- K250472: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2025), 0 descendants of its own
- K200123: Accessories for the SixFix® Hexapod Fixator (2020), 0 descendants of its own

## Indications for use
The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for post-traumatic 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.

Source page: https://510kreport.com/device/K190069
Methodology: https://510kreport.com/methodology