# K022185: Universal CMF System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Dec 17, 2002 after 167 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: 3 generations back to K954385 (1996). 10 ancestors in all.
33 later devices descend from it; 12 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014263: Newgen/Universal Mandibular System, Stryker Instruments (2002)
- K002619: Newgen System, Stryker Instruments (2000)
- K862482: Steinhauser Titanium Mini Bone Plates & Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) Summary page 1.
- K993862: Modus Sagittal Split Plate, The Straumann Co. (1999) Summary page 1.
- K862532: Dumbach Titanium Mesh Implant System, Walter Lorenz Surgical, Inc. (1986) Summary page 1.

## Most influential descendants
- K031659: Universal Neuro System (2003), 12 descendants of its own
- K112557: Stryker Universal Neuro 3 System (2012), 9 descendants of its own
- K120352: Stryker Quikflap Sterile Procedure Pack (2012), 4 descendants of its own
- K041651: Stryker Leibinger Skeletal Anchoring System (2004), 4 descendants of its own
- K161821: Stryker Universal Mesh (2016), 2 descendants of its own

## Indications for use
The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Source page: https://510kreport.com/device/K022185
Methodology: https://510kreport.com/methodology