# K042986: Modification to Synthes (Usa) (Synthes) Low Profile Neuro System

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Nov 17, 2004 after 19 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own

## Indications for use
The Synthes Cranial Plates are 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/K042986
Methodology: https://510kreport.com/methodology