# K031807: Synthes Low Profile Neuro System - 3 MM Screws

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Jul 2, 2003 after 21 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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 Low Profile Neuro System: named in the summary without a submission number

## Most influential descendants
- K123723: Synthes Matrixneuro Cranial Plating System (2013), 2 descendants of its own
- K140462: Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System) (2014), 1 descendant of its own
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Recalls of this device
- Feb 23, 2016 · Class II · Z-1327-2016: Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the s
- Feb 23, 2016 · Class II · Z-1326-2016: Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the s

## Indications for use
Synthes Low Profile Neuro 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/K031807
Methodology: https://510kreport.com/methodology