# K012910: The Bioplate Mandible Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Nov 20, 2001 after 82 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031989: Ortrautek Orthognathic System (2003), 5 descendants of its own
- K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems (2010), 4 descendants of its own
- 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

## Indications for use
The Bioplate Mandible Fixation System is intended for use in the treatment of fractures and reconstructive procedures of the facial skeleton and mandible, including orthognathic surgery. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K012910
Methodology: https://510kreport.com/methodology