# K050608: Synthes Carniofacial Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 18, 2005 after 69 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
0 of 23 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) Synthes Midfacial System: named in the summary without a submission number
- (no number) Synthes Orbital Mesh Plates F/Synthes Midfacial System: named in the summary without a submission number
- (no number) Synthes Maxillofacial Titanium Micro Set: named in the summary without a submission number
- (no number) Synthes Cranial Plates: named in the summary without a submission number
- (no number) Synthes 1.5 mm Self-tapping cortex screws: named in the summary without a submission number

## Most influential descendants
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface (2010), 12 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems (2010), 4 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own

## Recalls of this device
- Jun 16, 2020 · Class II · Z-2739-2020: One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with

## Indications for use
Synthes Craniofacial Plate and Screw System 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/K050608
Methodology: https://510kreport.com/methodology