# K110926: Bone Plate; Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomaterials Korea, Inc.
- Decided: Dec 8, 2011 after 251 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
a) The Bone Plates are indicated for orofacial (maxilla or mandible) fracture or damage. b) The Bone Screws are indicated for the fixation of the Bone Plate.

Source page: https://510kreport.com/device/K110926
Methodology: https://510kreport.com/methodology