# K121235: Leibinger Advance Internal Midface Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jan 9, 2014 after 625 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: 5 generations back to K792561 (1979). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 1.
- K022005: Synthes Midface Distractor, Synthes (Usa) (2002) Summary page 1.
- K003883: Molina Orbital Malar Distractor, KLS-Martin L.P. (2001) Summary page 1.
- K092743: The Leibinger Advance Internal Midface Distraction System, Stryker Craniomaxillofacial (2010) Summary page 1.

## Indications for use
The Leibinger Advance Internal Midface Distraction System is indicated for the treatment of syndromic and non-syndromic craniosynostosis, midface retrusion, congenital midfacial hypoplasia, and craniofacial dysostosis in patients two years of age and older.

Source page: https://510kreport.com/device/K121235
Methodology: https://510kreport.com/methodology