# K212058: Longeviti ClearFit™ OTS Cranial Implants

- Pathway: 510(k) (Traditional)
- Applicant: Longeviti Neuro Solutions, LLC
- Decided: Sep 8, 2021 after 69 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: 1 generation back to K202901 (2020). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202901: Longeviti ClearFit Cranial Implant, Longeviti Neuro Solutions, LLC (2020) Summary page 4.

## Most influential descendants
- K231920: Longeviti ClearFit OTS Cranial Implant (2023), 1 descendant of its own
- 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) (2026), 0 descendants of its own

## Indications for use
The Longeviti ClearFit OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

Source page: https://510kreport.com/device/K212058
Methodology: https://510kreport.com/methodology