# K162927: PRECICE UNYTE CoCr System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Apr 6, 2017 after 169 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 K160267 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160267: PRECICE Trauma Nail System, Ellipse Technologies, Incorporated (2016) Summary page 5.

## Indications for use
The PRECICE UNYTE CoCr System is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.

Source page: https://510kreport.com/device/K162927
Methodology: https://510kreport.com/methodology