# K171364: MP LeFort I Plates

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Jul 24, 2017 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
Longest line of descent: 4 generations back to K954385 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 6.

## Indications for use
The Stryker® Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy stabilization and rigid fixation of LeFort I fractures of the maxillofacial skeleton.

Source page: https://510kreport.com/device/K171364
Methodology: https://510kreport.com/methodology