# K102656: Synthes Dentoalveolar Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 20, 2010 after 96 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: 2 generations back to K953806 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980199: Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws, Synthes (Usa) (1998) Summary page 1.
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 1.
- K984230: Osteo-Mesh TM-300, Osteogenics Biomedical, Inc. (1999) Summary page 1.
- K021642: Synthes Craniofacial Plates, Synthes (Usa) (2002) Summary page 1.
- K030069: Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System, Synthes (Usa) (2003) Summary page 1.
- K033121: 1.3 & 1.5MM Contourable Titanium (TI.) Mesh Plates, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
The Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.

Source page: https://510kreport.com/device/K102656
Methodology: https://510kreport.com/methodology