# K112174: NCB Periprosthetic Femur Polyaxial Locking Plate System

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Oct 26, 2011 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NCB Periprosthetic Femur Polyaxial Locking Plate System: named in the summary without a submission number

## Indications for use
The NCB 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/K112174
Methodology: https://510kreport.com/methodology