# K023360: Leforte System Bone Plate

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Oct 25, 2002 after 18 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972323 (1997). 3 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972323: Osteo Bos System, Osteonics Corp. (1997) Summary page 1.
- K992961: Lorenz Small Fragment System, Walter Lorenz Surgical, Inc. (1999) Summary page 1.
- K983988: Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate, Syntec Scientific Corp. (1999) Summary page 1.

## Most influential descendants
- K131311: Arix Foot System (2013), 9 descendants of its own
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K161864: ARIX Foot System (2016), 5 descendants of its own
- K172260: Omni Foot Plating System (2017), 4 descendants of its own
- K170780: ARIX Foot System (2.3/2.8) (2017), 4 descendants of its own

## Indications for use
The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton).

Source page: https://510kreport.com/device/K023360
Methodology: https://510kreport.com/methodology