# K113219: Ellipse Precice Intramedullary Limb Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Oct 19, 2012 after 353 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: 5 generations back to K831576 (1983). 6 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 22 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.

## Most influential descendants
- K131490: Ellipse Precice Intramedullary Limb Lengthening System (2014), 14 descendants of its own
- K163368: Fitbone Taa (2017), 10 descendants of its own
- K203399: Fitbone (R) Taa (2021), 9 descendants of its own
- K220234: Precice Intramedullary Limb Lengthening System (2023), 3 descendants of its own
- K233867: Fitbone Trochanteric (2024), 2 descendants of its own

## Indications for use
The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

Source page: https://510kreport.com/device/K113219
Methodology: https://510kreport.com/methodology