# K022005: Synthes Midface Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 3, 2002 after 76 days
- Product code: JEY (Plate, Bone)
- 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; 3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092743: The Leibinger Advance Internal Midface Distraction System (2010), 3 descendants of its own
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant of its own
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K181504: Stryker Pediatric Mandibular Distractor 2 (2018), 0 descendants of its own
- K121235: Leibinger Advance Internal Midface Distraction System (2014), 0 descendants of its own

## Indications for use
The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.

Source page: https://510kreport.com/device/K022005
Methodology: https://510kreport.com/methodology