# K953806: Synthes (Usa) Midfacial System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 8, 1996 after 211 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.
240 later devices descend from it; 8 cite it directly.
0 of 241 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) Howmedica Luhr Pan Fixation System: named in the summary without a submission number

## Most influential descendants
- K983485: Synthes 1.3 MM Self-Drilling Screw (1998), 171 descendants of its own
- K013954: Lorenz Self Drilling Screws (2002), 117 descendants of its own
- K032228: Lorenz 2.4 Self Drilling Screws (2003), 101 descendants of its own
- K033740: Lorenz Sternal Closure System (2003), 100 descendants of its own
- K974554: Synthes Resorbable Fixation System (1998), 89 descendants of its own

## Indications for use
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K953806
Methodology: https://510kreport.com/methodology