# K260709: ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)

- Pathway: 510(k) (Traditional)
- Applicant: Longeviti Neuro Solutions
- Decided: Jun 25, 2026 after 113 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904111 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231920: Longeviti ClearFit OTS Cranial Implant, Longeviti Neuro Solutions, LLC (2023) Summary page 5.

## Indications for use
The Longeviti ClearFit(R) OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

Source page: https://510kreport.com/device/K260709
Methodology: https://510kreport.com/methodology