# K973018: Synthes Mini Lengthening Apparatus

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 10, 1997 after 89 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 K792561 (1979). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792561: Mini-H-Fixation, Geny Medical, Inc. (1979) Summary page 1.

## Most influential descendants
- K982604: Lorenz Maxilla (LE Fort) Distraction System (1998), 1 descendant of its own
- K031708: Osteomed Maxillary/Lefort Iii Distraction System (2003), 0 descendants of its own

## Indications for use
The Synthes MLA is intended for use as a stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required.

Source page: https://510kreport.com/device/K973018
Methodology: https://510kreport.com/methodology