# K141739: Residual Limb Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Oct 7, 2014 after 102 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.
No later device cites it as a predicate yet.
0 of 10 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.

## 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-1351-2021: 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 Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.

Source page: https://510kreport.com/device/K141739
Methodology: https://510kreport.com/methodology