# K982604: Lorenz Maxilla (LE Fort) Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Oct 23, 1998 after 88 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: 4 generations back to K792561 (1979). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 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.
- K972154: Cohen Distractor, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K973018: Synthes Mini Lengthening Apparatus, Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K031708: Osteomed Maxillary/Lefort Iii Distraction System (2003), 0 descendants of its own

## Indications for use
The Lorenz Maxilla (Le Fort) Distraction System is intended for use in the maxilla as a bone stabilizer and lengthening device when correction of congenital midfacial deficiencies or post traumatic defects require gradual bone distraction

Source page: https://510kreport.com/device/K982604
Methodology: https://510kreport.com/methodology