# K082175: Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Aug 13, 2008 after 12 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- 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 K971252 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070901: Modified Plate  Design for Bioplate Zip Craniotomy Fixation System, Bioplate, Inc. (2007) Summary page 1.
- K013050: The Bioplate Zip Craniotomy Fixation System, Bioplate, Inc. (2001)
- K020088: Modification of the Bioplate Zip Craniotomy Fixation System, Bioplate, Inc. (2002) Summary page 1.

## Indications for use
The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device 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.

Source page: https://510kreport.com/device/K082175
Methodology: https://510kreport.com/methodology