# K981275: Synthes (Usa) Ratcheting Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 25, 1998 after 78 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Synthes Mini Lengthening Apparatus (MLA): named in the summary without a submission number

## Indications for use
Synthes Ratcheting Distractor is intended for craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the mandible and maxilla. Specifically, it is indicated for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings.

Source page: https://510kreport.com/device/K981275
Methodology: https://510kreport.com/methodology