# K011380: Modification to the Bioplate Bioclip Craniotomy Fixation System

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: May 14, 2001 after 7 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013055: The Bioplate Bioclip Craniotomy Fixation System (2001), 1 descendant of its own
- K051293: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K011380
Methodology: https://510kreport.com/methodology