# K060492: Aesculap Craniofacial Plate and Screw

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Apr 7, 2006 after 42 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
Longest line of descent: 1 generation back to K923705 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923705: Aesculap Craniofacial Titanium Plates and Screws, Aesculap, Inc. (1994) Summary page 1.

## Indications for use
The Aesculap Craniofacial Plate and Screw System is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K060492
Methodology: https://510kreport.com/methodology