# K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Arrowhead Medical Device Technologies, LLC
- Decided: Aug 13, 2018 after 166 days
- Product code: OSN (Software For Diagnosis/Treatment)
- 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: 13 generations back to K962616 (1996). 60 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software, Smith & Nephew, Inc. (2011) Summary page 4.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 4.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex), Orthofix Srl (2014) Summary page 4.
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4, Orthofix Srl (2015) Summary page 4.
- K140550: Orthohub External Fixator Software, Orthohub, Inc. (2014) Summary page 4.

## Most influential descendants
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2019), 3 descendants of its own
- 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 Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: 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/K180539
Methodology: https://510kreport.com/methodology