# K021642: Synthes Craniofacial Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 14, 2002 after 86 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 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 no predicate by number.

## Most influential descendants
- K102656: Synthes Dentoalveolar Bone Fixation System (2010), 1 descendant of its own
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K101835: Medpor Fixation System-Cranial, Models 80080, 80079 (2010), 0 descendants of its own
- K091807: Medpor Fixation System (2010), 0 descendants of its own
- K073307: Max-Face Maxillofacial Osteosynthesis System (2008), 0 descendants of its own

## Indications for use
The Synthes Craniofacial 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/K021642
Methodology: https://510kreport.com/methodology