# K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Oct 16, 2008 after 118 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: 2 generations back to K961413 (1996). 6 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 28 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.
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006) Summary page 1.

## Most influential descendants
- K101696: Motionloc Screw for NCB Polyaxial Locking Plating System (2010), 10 descendants of its own
- K141493: Proximal Humerus Plating System (2015), 7 descendants of its own
- K123918: Motionloc Screw for NCB Polyaxial Locking Plate System (2013), 5 descendants of its own
- K161292: Distal Radius Plating System (2016), 4 descendants of its own
- K142938: G3 Active Plate Large Fragment System (2014), 3 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0332-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Sep 4, 2012 · Class II · Z-0246-2013: 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 Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

Source page: https://510kreport.com/device/K081759
Methodology: https://510kreport.com/methodology