# K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: May 7, 2001 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101235: Cranial Loop Cranial Bone Fixation System (2010), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K010361
Methodology: https://510kreport.com/methodology