# K013055: The Bioplate Bioclip Craniotomy Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Dec 7, 2001 after 87 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: 1 generation back to K001530 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001530: The Bioplate Bioclip Craniotomy Fixation System, Bioplate, Inc. (2000) Summary page 1.
- K002879: Modification to Bioplate Bioclip Craniotomy Fixation System, Bioplate, Inc. (2000) Summary page 1.
- K011380: Modification to the Bioplate Bioclip Craniotomy Fixation System, Bioplate, Inc. (2001) Summary page 1.

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

## Indications for use
The Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a cranial bone flap following a craniotomy procedure. The clip/plate is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants. The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions: The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm

Source page: https://510kreport.com/device/K013055
Methodology: https://510kreport.com/methodology