# K033092: The Gnathometer

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Gnathics, LLC
- Decided: Apr 21, 2004 after 205 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dento'facial deformities. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull Via tightening screws and a halo device, and not to be attached to the jaws.

Source page: https://510kreport.com/device/K033092
Methodology: https://510kreport.com/methodology