# K020407: Lorenz Blue Device

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Feb 22, 2002 after 16 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- 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 K992952 (1999). 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)
- K992952: Lorenz Distraction System, Walter Lorenz Surgical, Inc. (1999) Summary page 1.

## Indications for use
The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction. This is the same intended use as previously cleared for the Lorenz Distraction System (K992952).

Source page: https://510kreport.com/device/K020407
Methodology: https://510kreport.com/methodology