# K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 8, 2011 after 29 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: 10 generations back to K962616 (1996). 52 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 71 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 2.

## Most influential descendants
- K151881: X-Fix Line Additions (2016), 7 descendants of its own
- K140550: Orthohub External Fixator Software (2014), 5 descendants of its own
- K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation (2018), 4 descendants of its own
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2019), 3 descendants of its own
- K142520: Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software (2014), 3 descendants of its own

## Indications for use
The Smith & Nephew Spatialframe.com software is intended to be used as component of multilateral external fixation systems that are 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; pseudoarthrosis 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/K110069
Methodology: https://510kreport.com/methodology