# K042365: Synthes (Usa) Neuro Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 18, 2004 after 79 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Midfacial System: named in the summary without a submission number
- (no number) Synthes Maxillofacial Titanium Micro Set: named in the summary without a submission number
- (no number) Synthes 1.5 mm Self-tapping cortex screws: named in the summary without a submission number

## Most influential descendants
- K091686: Leforte Neurosystem Bone Screw (2009), 29 descendants of its own
- K091679: Leforte System Bone Plate (2009), 29 descendants of its own
- K112457: Leforte System Bone Plate & Screw (2012), 16 descendants of its own
- K112812: Leforte Neuro System Bone Plate (2012), 11 descendants of its own
- K131311: Arix Foot System (2013), 9 descendants of its own

## Recalls of this device
- Jun 18, 2020 · Class II · Z-2698-2020: One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identi

## Indications for use
Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K042365
Methodology: https://510kreport.com/methodology