# K023810: Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Dec 4, 2002 after 19 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: 2 generations back to K854886 (1986). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002)
- K980983: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1998) Summary page 1.
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1997) Summary page 1.
- K953273: Bioplate Rigid Fixation Bone Plating System, Biomedics (1995) Summary page 2.
- K943071: The Titanium Fixation System, Biomedics (1995) Summary page 2.

## Most influential descendants
- K051293: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System (2005), 0 descendants of its own

## Indications for use
The modified plates designs for use with 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/K023810
Methodology: https://510kreport.com/methodology