# K141447: Precice Trauma Nail System

- Pathway: 510(k) (Special)
- Applicant: Ellipse Technologies, Inc.
- Decided: Jun 30, 2014 after 28 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
Longest line of descent: 6 generations back to K831576 (1983). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113695: Ellipse Precice Trauma Nail System, Ellipse Technologies, Inc. (2012)

## Most influential descendants
- K142599: PRECISE Trauma Nail System (2015), 1 descendant of its own
- K152370: PRECICE Trauma Nail System (2015), 0 descendants of its own

## Indications for use
The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

Source page: https://510kreport.com/device/K141447
Methodology: https://510kreport.com/methodology