# K160995: NEOVIEW Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Jun 10, 2016 after 63 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: 11 generations back to K841189 (1984). 88 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102597: Piccolo Composite Plate System, N.M.B. Medical Applications, Ltd. (2011) Summary page 5.

## Most influential descendants
- K191118: Avanti Distal Radius and Forearm System (2019), 1 descendant of its own
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own

## Recalls of this device
- Jul 13, 2017 · Class II · Z-2869-2017: The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
- Dec 19, 2016 · Class II · Z-0954-2017: Dimensional non-conformity of the thread on the screw head.
- Dec 19, 2016 · Class II · Z-0952-2017: Dimensional non-conformity of the thread on the screw head.
- Dec 19, 2016 · Class II · Z-0953-2017: Dimensional non-conformity of the thread on the screw head.

## Indications for use
The NEOVIEW® Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius.

Source page: https://510kreport.com/device/K160995
Methodology: https://510kreport.com/methodology