# K101235: Cranial Loop Cranial Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Neos Surgery S.L
- Decided: Oct 25, 2010 after 175 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: 2 generations back to K002334 (2001). 6 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900, Medtronic PS Medical (2001) Summary page 1.
- K040080: Aesculap Absorbable Craniofix, Aesculap, Inc. (2004) Summary page 1.
- K972332: Aesculap Craniofix Titanium Clamp System, Aesculap, Inc. (1998) Summary page 1.

## Most influential descendants
- K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System (2013), 3 descendants of its own
- 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 System is a long-term implantable device indicated for post-craniotomy bone flap fixation.

Source page: https://510kreport.com/device/K101235
Methodology: https://510kreport.com/methodology