# K172628: PRECICE System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Sep 25, 2017 after 24 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: 1 generation back to K172061 (2017). 1 ancestor in all.
16 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)
- K172061: PRECICE UNYTE System, Nuvasive Specialized Orthopedics, Inc. (2017) Summary page 5.

## Most influential descendants
- K173129: PRECICE System (2017), 13 descendants of its own
- K180503: PRECICE STRYDE System (2018), 12 descendants of its own
- K182170: PRECICE® BONE TRANSPORT™ System (2019), 6 descendants of its own
- K193016: PRECICE Bone Transport System (2020), 4 descendants of its own
- K220234: Precice Intramedullary Limb Lengthening System (2023), 3 descendants of its own

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

Source page: https://510kreport.com/device/K172628
Methodology: https://510kreport.com/methodology