# K113695: Ellipse Precice Trauma Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Mar 28, 2012 after 103 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K831576 (1983). 17 ancestors in all.
3 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)
- K101997: Ellipse Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2011) Summary page 2.
- K092190: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications, Synthes (Usa) (2010) Summary page 2.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006)

## Most influential descendants
- K141447: Precice Trauma Nail System (2014), 2 descendants of its own
- K142599: PRECISE Trauma Nail System (2015), 1 descendant of its own
- K152370: PRECICE Trauma Nail System (2015), 0 descendants of its own

## Recalls of this device
- Oct 29, 2021 · Class II · Z-0319-2022: The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while u
- Feb 12, 2021 · Class II · Z-1350-2021: Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

## 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/K113695
Methodology: https://510kreport.com/methodology