# K092743: The Leibinger Advance Internal Midface Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Craniomaxillofacial
- Decided: Jan 15, 2010 after 129 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
Longest line of descent: 4 generations back to K792561 (1979). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972154: Cohen Distractor, Howmedica Leibinger, Inc. (1997) Summary page 2.
- K022005: Synthes Midface Distractor, Synthes (Usa) (2002) Summary page 2.
- K964649: Vazquez Diner Intraoral Distraction Device, Howmedica Leibinger, Inc. (1997) Summary page 2.
- K003883: Molina Orbital Malar Distractor, KLS-Martin L.P. (2001) Summary page 2.

## Most influential descendants
- K133398: Stryker Pediatric Mandible Distractor (2014), 1 descendant 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
Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler). and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.

Source page: https://510kreport.com/device/K092743
Methodology: https://510kreport.com/methodology