# K992873: Lorenz External Mandibular Distractor

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Sep 17, 1999 after 22 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 K955640 (1996). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955640: Lorenz Mandibular Distractor, Biomet, Inc. (1996) Summary page 1.

## Most influential descendants
- K034027: KLS Martin 3DX External Distraction System (2004), 3 descendants of its own
- K063792: Osteomed External Mandibular Distraction System (2007), 2 descendants of its own
- K123885: Osteomed Smartflex Cranial Spring Distractor (2013), 1 descendant of its own
- K230211: CranioXpand (2023), 0 descendants of its own

## Indications for use
The Lorenz External Mandibular Distractor is an external fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.

Source page: https://510kreport.com/device/K992873
Methodology: https://510kreport.com/methodology