# K172061: PRECICE UNYTE System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Aug 24, 2017 after 48 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
No predicates in its family tree.
17 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K172628: PRECICE System (2017), 16 descendants of its own
- 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

Source page: https://510kreport.com/device/K172061
Methodology: https://510kreport.com/methodology