# K182609: Delphos Implants Rigid Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Delphos Implants - Ind.Com. Importacao E Exportacao DE
- Decided: Mar 29, 2019 after 189 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: 6 generations back to K761228 (1976). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080694: Osteomed Modular Locking Fixation System, Osteomed LP (2008) Summary page 4.
- K112457: Leforte System Bone Plate & Screw, Arkin Consulting Group (2012) Summary page 4.
- K121589: Biomet Microfixation Facial Plating System, Biomet Microfixation (2012) Summary page 4.
- K180204: CranioMaxillofacial Fixation (CMF) System - CMF Visionare, Visionare, LLC (2018). Cleared while this submission was under review Summary page 4.
- K150965: LeForte System II, Jeil Medical Corporation (2015) Summary page 4.

## Indications for use
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The Delphos Implants Rigid Fixation System implants are intended for single use only.

Source page: https://510kreport.com/device/K182609
Methodology: https://510kreport.com/methodology