# K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Biomedics
- Decided: Sep 25, 1997 after 86 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.
14 later devices descend from it; 7 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biomedics, Inc.: named in the summary without a submission number
- (no number) W.L. Lorenz: named in the summary without a submission number
- (no number) Synthes (USA.): named in the summary without a submission number

## Most influential descendants
- K022890: Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (2002), 7 descendants of its own
- K030806: Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (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
- K062819: Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery (2006), 3 descendants of its own

## Indications for use
The plate and screw designs for use in conjunction with the I}ioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the facial skeleton and qon-}oaq bearing fixation, _lncludmg crania bone fixation, brow fixation, zygomatic fixation, orbital rim fixation , maxilary fixation, gratft fixation and membrane 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/K972463
Methodology: https://510kreport.com/methodology