# K192021: NCB Polyaxial Locking Plate System

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Aug 22, 2019 after 24 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961413 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042695: NCB Plating System, Zimmer GmbH (2004) Summary page 4.
- K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V, Zimmer GmbH (2008) Summary page 4.

## Most influential descendants
- K241754: NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate (2024), 0 descendants of its own

## Indications for use
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

Source page: https://510kreport.com/device/K192021
Methodology: https://510kreport.com/methodology