# K042695: NCB Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Oct 29, 2004 after 29 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961413 (1996). 3 ancestors in all.
68 later devices descend from it; 10 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- K003235: PE.R.I. II Knee Fracture System, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 1.

## Most influential descendants
- K061211: NCB Plating System, Proximal Tibia Plates (2006), 25 descendants of its own
- K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V (2008), 21 descendants of its own
- K121672: Aft Proximal Humerus Fracture Plate (2012), 20 descendants of its own
- K100111: NCB Periprosthetic Femur Polyaxial Locking Plate System (2010), 18 descendants of its own
- K133668: Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul (2014), 16 descendants of its own

## Recalls of this device
- Jul 13, 2012 · Class II · Z-2187-2012: Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.

## 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/K042695
Methodology: https://510kreport.com/methodology