# K152370: PRECICE Trauma Nail System

- Pathway: 510(k) (Special)
- Applicant: Ellipse Technologies, Incorporated
- Decided: Dec 22, 2015 after 123 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: 8 generations back to K831576 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142599: PRECISE Trauma Nail System, Ellipse Technologies, Incorporated (2015) Summary page 4.

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

Source page: https://510kreport.com/device/K152370
Methodology: https://510kreport.com/methodology