# K101997: Ellipse Intramedullary Limb Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Jul 12, 2011 after 362 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: 4 generations back to K831576 (1983). 5 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor), Orthodyne, Inc. (2001)
- K031219: Modification to Iskd (Intramedullary Skeletal Kinetic Distractor), Orthofix, Inc. (2003) Summary page 2.

## Most influential descendants
- K131677: Precice Intramedullary Limb Lengthening System (2013), 21 descendants of its own
- K133289: Precice Intramedullary Limb Lengthening System (2013), 19 descendants of its own
- K113219: Ellipse Precice Intramedullary Limb Lengthening System (2012), 15 descendants of its own
- K131490: Ellipse Precice Intramedullary Limb Lengthening System (2014), 14 descendants of its own
- K163368: Fitbone Taa (2017), 10 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 Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

Source page: https://510kreport.com/device/K101997
Methodology: https://510kreport.com/methodology