# K221855: Universal CMF System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Nov 9, 2022 after 135 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.
1 later device descends from it; 1 cites it directly.
0 of 13 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 5.
- K014263: Newgen/Universal Mandibular System, Stryker Instruments (2002) Summary page 5.

## Most influential descendants
- K240651: MRI Universal (2024), 0 descendants of its own

## Indications for use
Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

Source page: https://510kreport.com/device/K221855
Methodology: https://510kreport.com/methodology