# K031028: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Apr 28, 2003 after 27 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). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022890: Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002) Summary page 2.
- K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002)
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1997) Summary page 1.
- K943071: The Titanium Fixation System, Biomedics (1995) Summary page 2.

## Indications for use
The BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. 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/K031028
Methodology: https://510kreport.com/methodology