# K193617: Precice® Screws

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: May 8, 2020 after 134 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 K962616 (1996). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172628: PRECICE System, Nuvasive Specialized Orthopedics, Inc. (2017) Summary page 4.
- K180503: PRECICE STRYDE System, Nuvasive Specialized Orthopedics, Inc. (2018) Summary page 4.
- K182170: PRECICE® BONE TRANSPORT™ System, Nuvasive Specialized Orthopedics, Inc. (2019) Summary page 4.
- K192181: PRECICE Plating System, Nuvasive Specialized Orthopedics, Inc. (2019) Summary page 4.

## Indications for use
The Precice® Screws are provided sterile and intended to be used with the systems below: The Precice® System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. 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. The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.

Source page: https://510kreport.com/device/K193617
Methodology: https://510kreport.com/methodology