# K981890: Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 18, 1998 after 81 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: 1 generation back to K954385 (1996). 1 ancestor in all.
35 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K993862: Modus Sagittal Split Plate (1999), 34 descendants of its own
- K022185: Universal CMF System (2002), 33 descendants of its own
- 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

## Indications for use
The Synthes Mandibular Modular Fixation System is intended for use in oral, maxillofacial surgery, such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic surgery; and craniofacial surgery.

Source page: https://510kreport.com/device/K981890
Methodology: https://510kreport.com/methodology