# K192217: NCB Plating System Distal Femur and Proximal Tibia

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Sep 13, 2019 after 29 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.
11 later devices descend from it; 3 cite it directly.
0 of 19 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.
- K061211: NCB Plating System, Proximal Tibia Plates, Zimmer GmbH (2006) Summary page 4.

## Most influential descendants
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K233017: TM Plating System (2023), 1 descendant of its own

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

Source page: https://510kreport.com/device/K192217
Methodology: https://510kreport.com/methodology