# K160325: PRECICE Intramedullary Limb Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Apr 4, 2016 after 59 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: 9 generations back to K831576 (1983). 10 ancestors in all.
5 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)
- K151131: PRECICE Intramedullary Limb Lengthening System, Ellipse Technologies, Incorporated (2015) Summary page 4.

## Most influential descendants
- 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
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K160325
Methodology: https://510kreport.com/methodology