# K112812: Leforte Neuro System Bone Plate

- Pathway: 510(k) (Special)
- Applicant: Jeil Medical Corporation
- Decided: Feb 22, 2012 after 148 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953806 (1996). 7 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091679: Leforte System Bone Plate, Jeil Medical Corporation (2009) Summary page 1.
- K103778: Leforte Neuro System Bone Plate, Jeil Medical Corporation (2011) Summary page 1.
- K091686: Leforte Neurosystem Bone Screw, Jeil Medical Corporation (2009) Summary page 1.

## Most influential descendants
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K141452: Leforte Neuro System Bone Plate and Screw (2014), 4 descendants of its own
- K210099: Meticuly Patient-Specific Titanium Mesh Implant (2021), 2 descendants of its own
- K183352: Optimus Neuro System (2019), 2 descendants of its own
- K190811: Optimus NEURO System - Sterile Kit (2019), 1 descendant of its own

## Indications for use
This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

Source page: https://510kreport.com/device/K112812
Methodology: https://510kreport.com/methodology