# K061211: NCB Plating System, Proximal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Jun 14, 2006 after 44 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961413 (1996). 6 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 32 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 1.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 1.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K192217: NCB Plating System Distal Femur and Proximal Tibia (2019), 11 descendants of its own
- K101696: Motionloc Screw for NCB Polyaxial Locking Plating System (2010), 10 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K123918: Motionloc Screw for NCB Polyaxial Locking Plate System (2013), 5 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

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0303-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Sep 4, 2012 · Class II · Z-0243-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0244-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0245-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## 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/K061211
Methodology: https://510kreport.com/methodology