# K955640: Lorenz Mandibular Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 14, 1996 after 64 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
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992873: Lorenz External Mandibular Distractor (1999), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K955640
Methodology: https://510kreport.com/methodology