# K192310: Flap Fixator, Burr Hole Cover

- Pathway: 510(k) (Traditional)
- Applicant: Ossaware Biotech Co., Ltd.
- Decided: Jun 3, 2020 after 282 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002334 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System, Neos Surgery S.L (2013) Summary page 4.
- K160739: Cranial COVER, Neos Surgery S.L (2016) Summary page 4.

## Indications for use
CirFIX Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.

Source page: https://510kreport.com/device/K192310
Methodology: https://510kreport.com/methodology