# K241754: NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Switzerland Manufacturing GmbH
- Decided: Aug 15, 2024 after 58 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: 6 generations back to K981372 (1998). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192217: NCB Plating System Distal Femur and Proximal Tibia, Zimmer GmbH (2019) Summary page 5.
- K192021: NCB Polyaxial Locking Plate System, Zimmer GmbH (2019) Summary page 5.
- K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V, Zimmer GmbH (2008) Summary page 5.
- K061211: NCB Plating System, Proximal Tibia Plates, Zimmer GmbH (2006) Summary page 5.
- K042695: NCB Plating System, Zimmer GmbH (2004) Summary page 5.
- K120772: NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate, Zimmer GmbH (2012) Summary page 5.
- K100111: NCB Periprosthetic Femur Polyaxial Locking Plate System, Zimmer, Inc. (2010) Summary page 5.
- K113718: NCB Straight Narrow Shaft Plates, Zimmer GmbH (2012) Summary page 5.

## Indications for use
NCB® Polyaxial Locking Plate System: The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies. NCB® Periprosthetic Femur Plate System: The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures. If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty. The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate. NCB® Cable Button: The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies. NCB® Straight Narrow Shaft Plate The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including periprosthetic fractures.

Source page: https://510kreport.com/device/K241754
Methodology: https://510kreport.com/methodology