# K954385: Synthes Mandibular Modular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 8, 1996 after 171 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.
494 later devices descend from it; 7 cite it directly.
0 of 495 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) W. Lorenz Wiirzburg Titanium Miniplate System: named in the summary without a submission number

## Most influential descendants
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS) (1998), 457 descendants of its own
- K030448: Osteomed 2.0 Locking Plates and Screws (2003), 444 descendants of its own
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), 435 descendants of its own
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own

## Indications for use
The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in: Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and craniofacial surgery ENT: trauma of the nasal bones Neurosurgery: osteosynthesis of the cranial bones.

Source page: https://510kreport.com/device/K954385
Methodology: https://510kreport.com/methodology