# K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems

- Pathway: 510(k) (Traditional)
- Applicant: Frontier Devices, Inc.
- Decided: May 7, 2010 after 323 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: 7 generations back to K761228 (1976). 31 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030806: Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2003) Summary page 1.
- K031989: Ortrautek Orthognathic System, Tekka (2003) Summary page 2.
- K012910: The Bioplate Mandible Fixation System, Bioplate, Inc. (2001) Summary page 2.
- K050608: Synthes Carniofacial Plate and Screw System, Synthes (Usa) (2005) Summary page 2.

## Most influential descendants
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The Frontier Devices Mandible Reconstructive System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Frontier Devices Mesh System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K091812
Methodology: https://510kreport.com/methodology