# K240137: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

- Pathway: 510(k) (Special)
- Applicant: Neos Surgery S.L
- Decided: Feb 16, 2024 after 29 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: 4 generations back to K002334 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 5.

## 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-craniotomy bone flap fixation. In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP (L) (FC050100) are for use within the osteotomy line (calvarial gap) while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.

Source page: https://510kreport.com/device/K240137
Methodology: https://510kreport.com/methodology