# K210953: SMART Taylor Spatial Frame

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 29, 2021 after 121 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: 12 generations back to K962616 (1996). 54 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 57 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 4.
- K142520: Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software, Smith & Nephew, Inc. (2014) Summary page 4.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 4.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.

## Most influential descendants
- K253202: Hoffmann LRF System (2025), 0 descendants of its own
- K221792: Acute QC Strut and Components (2022), 0 descendants of its own

## Indications for use
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 Pseudarthrosis of long bones Limb lengthening by distraction Correction of bony or soft tissue deformities Joint arthrodesis Infected fractures Nonunions

Source page: https://510kreport.com/device/K210953
Methodology: https://510kreport.com/methodology