# K131674: Prebent Plating with Virtual Surgical Planning

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation
- Decided: Aug 8, 2013 after 62 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: 5 generations back to K042434 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063052: Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates, Walter Lorenz Surgical, Inc. (2007) Summary page 1.
- K113152: Ultrasonic Surgery Machine, Dmetec.Co., Ltd. (2012)
- K081067: Fracture/Reconstruction System (Traumaone), Biomet Microfixation, Inc. (2008) Summary page 1.

## Indications for use
For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Source page: https://510kreport.com/device/K131674
Methodology: https://510kreport.com/methodology