# K964328: Synthes (Usa) Synthes MMFS-Adjustable Sagittal Split Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 13, 1996 after 44 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
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K964328
Methodology: https://510kreport.com/methodology