# K042987: Modification to Synthes Cranial Plates

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Nov 23, 2004 after 25 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 Cranial Plates: named in the summary without a submission number

## Most influential descendants
- K100205: Frontier Devices Neuro System (2010), 5 descendants of its own
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K183352: Optimus Neuro System (2019), 2 descendants of its own
- K190811: Optimus NEURO System - Sterile Kit (2019), 1 descendant of its own
- K212391: MCI-Neuro Fixation System (2022), 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/K042987
Methodology: https://510kreport.com/methodology