# K100111: NCB Periprosthetic Femur Polyaxial Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 12, 2010 after 88 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981372 (1998). 16 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 1.
- K042695: NCB Plating System, Zimmer GmbH (2004) Summary page 1.

## Most influential descendants
- K113718: NCB Straight Narrow Shaft Plates (2012), 7 descendants of its own
- K120772: NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate (2012), 6 descendants of its own
- K123918: Motionloc Screw for NCB Polyaxial Locking Plate System (2013), 5 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0304-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0329-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Indications for use
The NCR Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including: * Periprosthetic fractures * Comminuted fractures * Supracondylar fractures * Fractures in osteopenic bone * Nonunions * Malunions

Source page: https://510kreport.com/device/K100111
Methodology: https://510kreport.com/methodology