# K023365: Leforte System Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Apr 18, 2003 after 193 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792022 (1979). 12 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971069: Twist-Off (TM) Screw, Landos, Inc. (1997) Summary page 1.
- K970549: Titanium Alloy Bone Screws, Aesculap, Inc. (1997) Summary page 1.
- K960533: K3 Bone Screw System, Kinetikos Medical, Inc. (1996) 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 Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones.

Source page: https://510kreport.com/device/K023365
Methodology: https://510kreport.com/methodology