# K013672: Bruges Distraction - Anchoring - Osteosynthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Azary Technologies, LLC
- Decided: Apr 8, 2002 after 153 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 K792561 (1979). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972166: Guerrero - Bell Distractor, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K010139: Zurich Distraction System, KLS-Martin L.P. (2001) Summary page 1.
- K992682: Modus 2.5 Mandibular Reconstruction Set, Medartis AG (1999) Summary page 1.

## Indications for use
The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).

Source page: https://510kreport.com/device/K013672
Methodology: https://510kreport.com/methodology