# K030806: Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Apr 8, 2003 after 26 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). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013954: Lorenz Self Drilling Screws, Walter Lorenz Surgical, Inc. (2002)
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 1.
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 1.
- K974785: Auto-Drive Bone Screw, Osteomed Corp. (1998) Summary page 1.
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1997) Summary page 2.
- K022890: Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## 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. The supplementary IabeVlabeling material will be used for training and promotional purposes and does not affect the intended use of the devices.

Source page: https://510kreport.com/device/K030806
Methodology: https://510kreport.com/methodology