# K970748: Taylor Spatial Frame External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: May 9, 1997 after 67 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
No predicates in its family tree.
65 later devices descend from it; 14 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093047: Smith & Nephew Circular Fixation System (2010), 51 descendants of its own
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- K143125: Orthofix True Lok Hexapod System VI.3 (2014), 26 descendants of its own
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (2015), 19 descendants of its own
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software (2011), 18 descendants of its own

## Indications for use
The Taylor Spatial Frame (TSF) external fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long benes, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The TSF is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

Source page: https://510kreport.com/device/K970748
Methodology: https://510kreport.com/methodology