# K072463: Satyrne Interflex Mandibular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Satyrne Medical
- Decided: Nov 29, 2007 after 90 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: 4 generations back to K954385 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 1.
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 1.

## Indications for use
Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K072463
Methodology: https://510kreport.com/methodology