# K870961: Richards External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Richards Medical Co., Inc.
- Decided: Mar 19, 1987 after 9 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.
62 later devices descend from it; 10 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K870961
Methodology: https://510kreport.com/methodology