# K073307: Max-Face Maxillofacial Osteosynthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Technology USA, Inc.
- Decided: Oct 29, 2008 after 341 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 K944565 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 1.
- K021642: Synthes Craniofacial Plates, Synthes (Usa) (2002) Summary page 1.

## Indications for use
The MaxFace Maxillofacial Ostheosynthesis System is indicated for trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.

Source page: https://510kreport.com/device/K073307
Methodology: https://510kreport.com/methodology