# K191336: PRECICE System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Sep 26, 2019 after 132 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: 11 generations back to K831576 (1983). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170169: PRECICE Intramedullary Limb Lengthening System, Nuvasive Specialized Orthopedics, Inc. (2017) Summary page 4.
- K173129: PRECICE System, Nuvasive Specialized Orthopedics, Inc. (2017) Summary page 4.
- K180503: PRECICE STRYDE System, Nuvasive Specialized Orthopedics, Inc. (2018) Summary page 4.

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

## Indications for use
The PRECICE® System is indicated for limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones.

Source page: https://510kreport.com/device/K191336
Methodology: https://510kreport.com/methodology