# K182170: PRECICE® BONE TRANSPORT™ System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Feb 5, 2019 after 179 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K172061 (2017). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K193016: PRECICE Bone Transport System (2020), 4 descendants of its own
- K201567: Precice® Bone Transport System (2020), 3 descendants of its own
- K232169: FITBONE® Transport and Lengthening System (2024), 2 descendants of its own
- K260146: Fitbone® Transport and Lengthening System (2026), 0 descendants of its own
- K253991: Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA (2026), 0 descendants of its own

## Recalls of this device
- Feb 12, 2021 · Class II · Z-1324-2021: Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

## Indications for use
The PRECICE® BONE TRANSPORT™ 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/K182170
Methodology: https://510kreport.com/methodology