# K220234: Precice Intramedullary Limb Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Mar 15, 2023 after 412 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). 14 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172628: PRECICE System, Nuvasive Specialized Orthopedics, Inc. (2017) Summary page 4.
- K203399: Fitbone (R) Taa, Wittenstein Intens GmbH (2021) Summary page 4.

## Most influential descendants
- K232267: Precice Max System (2023), 1 descendant of its own
- K230765: Precice Ankle Salvage System (2023), 1 descendant of its own
- K261651: Precice™ Max System and Precice™ Ankle Salvage System (2026), 0 descendants of its own

## Indications for use
The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, nonunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).

Source page: https://510kreport.com/device/K220234
Methodology: https://510kreport.com/methodology