# K151131: PRECICE Intramedullary Limb Lengthening System

- Pathway: 510(k) (Special)
- Applicant: Ellipse Technologies, Incorporated
- Decided: Jun 19, 2015 after 52 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: 8 generations back to K831576 (1983). 9 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141023: Precice Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2014) Summary page 5.
- K133289: Precice Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2013) Summary page 5.
- K131677: Precice Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2013) Summary page 5.

## Most influential descendants
- K160325: PRECICE Intramedullary Limb Lengthening System (2016), 5 descendants of its own
- K170169: PRECICE Intramedullary Limb Lengthening System (2017), 2 descendants of its own
- K191336: PRECICE System (2019), 1 descendant of its own
- K170346: PRECICE Intramedullary Limb Lengthening System (2017), 1 descendant of its own
- K261651: Precice™ Max System and Precice™ Ankle Salvage System (2026), 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-1349-2021: 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 System is indicated for limb lengthening of the tibia and femur.

Source page: https://510kreport.com/device/K151131
Methodology: https://510kreport.com/methodology