# K192181: PRECICE Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Nov 7, 2019 after 87 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 10 generations back to K962616 (1996). 79 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031875: Inter-OS Limb Lengthener, Inter-Os Technologies (2003) Summary page 4.
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System, OrthoPediatrics Corp. (2011) Summary page 4.

## Most influential descendants
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own
- K193617: Precice® Screws (2020), 0 descendants of its own

## Recalls of this device
- Feb 12, 2021 · Class II · Z-1325-2021: 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® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.

Source page: https://510kreport.com/device/K192181
Methodology: https://510kreport.com/methodology