# K950394: Tibia-Talus-Calcaneus Nail

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: May 19, 1995 after 107 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K043052: Trigen Hindfoot Fusion Nail (2004), 13 descendants of its own
- K102413: Fuze: Intramedullary Internal Fixation Nail (2011), 7 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own

Source page: https://510kreport.com/device/K950394
Methodology: https://510kreport.com/methodology