# K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Neos Surgery S.L
- Decided: Sep 30, 2013 after 90 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: 3 generations back to K002334 (2001). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101235: Cranial Loop Cranial Bone Fixation System, Neos Surgery S.L (2010) Summary page 4.

## Most influential descendants
- K160739: Cranial COVER (2016), 1 descendant of its own
- K240137: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (2024), 0 descendants of its own
- K192310: Flap Fixator, Burr Hole Cover (2020), 0 descendants of its own

## Indications for use
The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL, are long-term implantable devices indicated for post-craniotamy bone flap fixation. In cranial bone fixation procedures, the Cranial LOOP (FCO50000) and Cranial LOOP L (FCO5O1 00) are for use within the calvarial gap while the Cranial LOOP XL (FC050200) is to be used for covering a standard 14 mm cranial burr hale only.

Source page: https://510kreport.com/device/K132044
Methodology: https://510kreport.com/methodology