# K043555: Synthes 9USA) Alveolar Ridge Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 12, 2005 after 106 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KLS Martin - Track 1.0 & 1.5mm System: named in the summary without a submission number
- (no number) Lorenz Surgical, Inc - Lorenz Distraction System: named in the summary without a submission number

## Most influential descendants
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K080458: Mis Crest Widener (2008), 0 descendants of its own

## Indications for use
The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of: * Trauma * Resorption after dental extraction * Periodontal disease * Tumor resection * Congenital deformity

Source page: https://510kreport.com/device/K043555
Methodology: https://510kreport.com/methodology