# K132600: Facial Prebent Plating with Virtual Surgical Planning

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation
- Decided: Oct 2, 2013 after 43 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
Longest line of descent: 6 generations back to K761228 (1976). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121589: Biomet Microfixation Facial Plating System, Biomet Microfixation (2012) Summary page 1.
- K120956: VSP System, Medical Modeling, Inc. (2012) Summary page 1.

## Indications for use
These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed

Source page: https://510kreport.com/device/K132600
Methodology: https://510kreport.com/methodology