# K050669: Jeil Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: May 26, 2005 after 72 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 K894844 (1990). 39 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011698: Straumann GBR System, Institut Straumann AG (2001) Summary page 1.
- K984230: Osteo-Mesh TM-300, Osteogenics Biomedical, Inc. (1999) Summary page 1.
- K033767: Dual Top Anchor System Screws, Jeil Medical Corporation (2004) Summary page 1.
- K023360: Leforte System Bone Plate, Jeil Medical Corporation (2002) Summary page 1.
- K023365: Leforte System Bone Screw, Jeil Medical Corporation (2003) Summary page 1.

## Most influential descendants
- K170697: GBR system (2018), 2 descendants of its own
- K143730: GBR System (2015), 2 descendants of its own
- K182881: Bone Screw, Bone Tack (2019), 1 descendant of its own
- K160991: Neo GBR System (2017), 1 descendant of its own
- K251569: Bone Screw (2025), 0 descendants of its own

## Indications for use
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only

Source page: https://510kreport.com/device/K050669
Methodology: https://510kreport.com/methodology